Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05459116

Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation

This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.

Recruiting

Interested in participating?

Request Info

Key information

Age range

29 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital (UZA), Edegem, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 28 days
  • weight > 3kg
  • requiring invasive mechanical ventilation
  • anticipated length of ventilation > 48h

Exclusion criteria

  • refusal of consent
  • mechanical ventilation ≤ 2 weeks before inclusion
  • known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
  • contra-indication to the placement of a naso-gastric esophageal balloon catheter

Treatment and study plan

Placement of nasogastric balloon

Device

A nasogastric balloon catheter will be inserted after inclusion. This will be a NutriVent (Sidam S.R.L., Mirandola, Italy) for patients >40kg, and a SmartCath Esophageal pressure catheter (Vyaire/Carefusion) for patients <40kg. This placement is similar to a standard nasogastric tube placement, which is a common procedure in an ICU. Potential minor side effects include a nosebleed, sore throat and erosion of the nose where the tube is anchored. All patients will receive this intervention. When the esophageal catheter becomes displaced or is accidentally removed during the study period, it will be replaced.

Primary outcomes

  1. Tidal esophageal pressure swing (∆Pes) - D1

    Time frame: ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

  2. Tidal esophageal pressure swing (∆Pes) - D2

    Time frame: ∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

  3. Tidal esophageal pressure swing (∆Pes) - D3

    Time frame: ∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

  4. Tidal esophageal pressure swing (∆Pes) - D4

    Time frame: ∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

  5. Tidal esophageal pressure swing (∆Pes) - D5

    Time frame: ∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

  6. Tidal esophageal pressure swing (∆Pes) - D6

    Time frame: ∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

  7. Tidal esophageal pressure swing (∆Pes) - D7

    Time frame: ∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

  8. Tidal esophageal pressure swing (∆Pes) - D8

    Time frame: ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation

    Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

Secondary outcomes

  1. Transpulmonary driving pressure (ΔPL) - D1

    Time frame: ∆PL (average over 1 minute recording) at day 1 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  2. Transpulmonary driving pressure (ΔPL) - D2

    Time frame: ∆PL (average over 1 minute recording) at day 2 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  3. Transpulmonary driving pressure (ΔPL) - D3

    Time frame: ∆PL (average over 1 minute recording) at day 3 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  4. Transpulmonary driving pressure (ΔPL) - D4

    Time frame: ∆PL (average over 1 minute recording) at day 4 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  5. Transpulmonary driving pressure (ΔPL) - D5

    Time frame: ∆PL (average over 1 minute recording) at day 5 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  6. Transpulmonary driving pressure (ΔPL) - D6

    Time frame: ∆PL (average over 1 minute recording) at day 6 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  7. Transpulmonary driving pressure (ΔPL) - D7

    Time frame: ∆PL (average over 1 minute recording) at day 7 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  8. Transpulmonary driving pressure (ΔPL) - D8

    Time frame: ∆PL (average over 1 minute recording) at day 8 of mechanical ventilation

    ∆PL is calculated as change in airway pressure minus change in esophageal pressure

  9. Occlusion pressure (P0.1) - D1

    Time frame: P0.1 (average of 3 breaths) at day 1 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  10. Occlusion pressure (P0.1) - D2

    Time frame: P0.1 (average of 3 breaths) at day 2 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  11. Occlusion pressure (P0.1) - D3

    Time frame: P0.1 (average of 3 breaths) at day 3 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  12. Occlusion pressure (P0.1) - D4

    Time frame: P0.1 (average of 3 breaths) at day 4 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  13. Occlusion pressure (P0.1) - D5

    Time frame: P0.1 (average of 3 breaths) at day 5 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  14. Occlusion pressure (P0.1) - D6

    Time frame: P0.1 (average of 3 breaths) at day 6 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  15. Occlusion pressure (P0.1) - D7

    Time frame: P0.1 (average of 3 breaths) at day 7 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  16. Occlusion pressure (P0.1) - D8

    Time frame: P0.1 (average of 3 breaths) at day 8 of mechanical ventilation

    P0.1 is measured during the first 100 milliseconds of a breath

  17. End-expiratory diaphragm thickness (DTee) - D1

    Time frame: DTee (average of 3 breaths) at day 1 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  18. End-expiratory diaphragm thickness (DTee) - D2

    Time frame: DTee (average of 3 breaths) at day 2 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  19. End-expiratory diaphragm thickness (DTee) - D3

    Time frame: DTee (average of 3 breaths) at day 3 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  20. End-expiratory diaphragm thickness (DTee) - D4

    Time frame: DTee (average of 3 breaths) at day 4 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  21. End-expiratory diaphragm thickness (DTee) - D5

    Time frame: DTee (average of 3 breaths) at day 5 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  22. End-expiratory diaphragm thickness (DTee) - D6

    Time frame: DTee (average of 3 breaths) at day 6 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  23. End-expiratory diaphragm thickness (DTee) - D7

    Time frame: DTee (average of 3 breaths) at day 7 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  24. End-expiratory diaphragm thickness (DTee) - D8

    Time frame: DTee (average of 3 breaths) at day 8 of mechanical ventilation

    Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  25. Diaphragm thickening fraction (DTF) measured with ultrasound - D1

    Time frame: DTF (average of 3 breaths) at day 1 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  26. Diaphragm thickening fraction (DTF) measured with ultrasound - D2

    Time frame: DTF (average of 3 breaths) at day 2 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  27. Diaphragm thickening fraction (DTF) measured with ultrasound - D3

    Time frame: DTF (average of 3 breaths) at day 3 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  28. Diaphragm thickening fraction (DTF) measured with ultrasound - D4

    Time frame: DTF (average of 3 breaths) at day 4 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  29. Diaphragm thickening fraction (DTF) measured with ultrasound - D5

    Time frame: DTF (average of 3 breaths) at day 5 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  30. Diaphragm thickening fraction (DTF) measured with ultrasound - D6

    Time frame: DTF (average of 3 breaths) at day 6 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  31. Diaphragm thickening fraction (DTF) measured with ultrasound - D7

    Time frame: DTF (average of 3 breaths) at day 7 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  32. Diaphragm thickening fraction (DTF) measured with ultrasound - D8

    Time frame: DTF (average of 3 breaths) at day 8 of mechanical ventilation

    DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100.

    The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.

  33. Duration of mechanical ventilation

    Time frame: From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 4 months

    Cumulative duration of mechanical ventilation in days (excluding non-invasive ventilation)

  34. Maximal inspiratory pressure (MIP) - D1

    Time frame: MIP at day 1 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  35. Maximal inspiratory pressure (MIP) - D2

    Time frame: MIP at day 2 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  36. Maximal inspiratory pressure (MIP) - D3

    Time frame: MIP at day 3 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  37. Maximal inspiratory pressure (MIP) - D4

    Time frame: MIP at day 4 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  38. Maximal inspiratory pressure (MIP) - D5

    Time frame: MIP at day 5 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  39. Maximal inspiratory pressure (MIP) - D6

    Time frame: MIP at day 6 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  40. Maximal inspiratory pressure (MIP) - D7

    Time frame: MIP at day 7 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  41. Maximal inspiratory pressure (MIP) - D8

    Time frame: MIP at day 8 of mechanical ventilation

    MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)

  42. Need for tracheal reintubation after tracheal extubation

    Time frame: From date of inclusion until the date of reintubation or date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months.

  43. Lung ultrasound scores (LUSS) - D1

    Time frame: LUSS at day 1 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  44. Lung ultrasound scores (LUSS) - D2

    Time frame: LUSS at day 2 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  45. Lung ultrasound scores (LUSS) - D3

    Time frame: LUSS at day 3 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  46. Lung ultrasound scores (LUSS) - D4

    Time frame: LUSS at day 4 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  47. Lung ultrasound scores (LUSS) - D5

    Time frame: LUSS at day 5 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  48. Lung ultrasound scores (LUSS) - D6

    Time frame: LUSS at day 6 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  49. Lung ultrasound scores (LUSS) - D7

    Time frame: LUSS at day 7 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  50. Lung ultrasound scores (LUSS) - D8

    Time frame: LUSS at day 8 of mechanical ventilation

    Measured once daily for the first 8 days of mechanical ventilation

  51. ICU length of stay

    Time frame: From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months

    Duration to live discharge from the ICU

  52. ICU mortality

    Time frame: From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months

  53. Hospital length of stay

    Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months

    Duration to live discharge from hospital

  54. Duration to decease

    Time frame: From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months

    Cumulative time to death counting from the day of intubation

  55. Hospital mortality

    Time frame: From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months

  56. Presence of clinical signs of muscle weakness at ICU discharge

    Time frame: From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months

  57. Presence of clinical signs of muscle weakness at hospital discharge

    Time frame: From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months

  58. ICU readmission rate within 48 hours

    Time frame: From date of ICU discharge until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months

  59. Inspiratory muscle pressure (Pmus) - D1

    Time frame: Pmus at day 1 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  60. Inspiratory muscle pressure (Pmus) - D2

    Time frame: Pmus at day 2 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  61. Inspiratory muscle pressure (Pmus) - D3

    Time frame: Pmus at day 3 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  62. Inspiratory muscle pressure (Pmus) - D4

    Time frame: Pmus at day 4 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  63. Inspiratory muscle pressure (Pmus) - D5

    Time frame: Pmus at day 5 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  64. Inspiratory muscle pressure (Pmus) - D6

    Time frame: Pmus at day 6 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  65. Inspiratory muscle pressure (Pmus) - D7

    Time frame: Pmus at day 7 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  66. Inspiratory muscle pressure (Pmus) - D8

    Time frame: Pmus at day 8 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  67. Occlusion pressure (∆Pocc) - D1

    Time frame: ∆Pocc at day 1 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  68. Occlusion pressure (∆Pocc) - D2

    Time frame: ∆Pocc at day 2 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  69. Occlusion pressure (∆Pocc) - D3

    Time frame: ∆Pocc at day 3 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  70. Occlusion pressure (∆Pocc) - D4

    Time frame: ∆Pocc at day 4 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  71. Occlusion pressure (∆Pocc) - D5

    Time frame: ∆Pocc at day 5 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  72. Occlusion pressure (∆Pocc) - D6

    Time frame: ∆Pocc at day 6 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  73. Occlusion pressure (∆Pocc) - D7

    Time frame: ∆Pocc at day 7 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  74. Occlusion pressure (∆Pocc) - D8

    Time frame: ∆Pocc at day 8 of mechanical ventilation

    Measured at least once daily for the first 8 days of mechanical ventilation

  75. Esophageal pressure-time product (PTPes) - D1

    Time frame: PTPes at day 1 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  76. Esophageal pressure-time product (PTPes) - D2

    Time frame: PTPes at day 2 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  77. Esophageal pressure-time product (PTPes) - D3

    Time frame: PTPes at day 3 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  78. Esophageal pressure-time product (PTPes) - D4

    Time frame: PTPes at day 4 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  79. Esophageal pressure-time product (PTPes) - D5

    Time frame: PTPes at day 5 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  80. Esophageal pressure-time product (PTPes) - D6

    Time frame: PTPes at day 6 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  81. Esophageal pressure-time product (PTPes) - D7

    Time frame: PTPes at day 7 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  82. Esophageal pressure-time product (PTPes) - D8

    Time frame: PTPes at day 8 of mechanical ventilation

    Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.

  83. Dead space ventilation (VD) - D1

    Time frame: VD at day 1 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

  84. Dead space ventilation (VD) - D2

    Time frame: VD at day 2 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

  85. Dead space ventilation (VD) - D3

    Time frame: VD at day 3 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

  86. Dead space ventilation (VD) - D4

    Time frame: VD at day 4 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

  87. Dead space ventilation (VD) - D5

    Time frame: VD at day 5 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

  88. Dead space ventilation (VD) - D6

    Time frame: VD at day 6 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

  89. Dead space ventilation (VD) - D7

    Time frame: VD at day 7 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

  90. Dead space ventilation (VD) - D8

    Time frame: VD at day 8 of mechanical ventilation

    Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • KU Leuven
  • Research Foundation Flanders
  • The Hospital for Sick Children
  • Universitaire Ziekenhuizen KU Leuven
  • Universiteit Antwerpen
  • University of Toronto

Registry information

Acronym: VIREM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.