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Completed

NCT Number: NCT05652699

Effect of HFNO Therapy on Respiratory Effort After Extubation

Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Monitoring weaning from invasive mechanical ventilation while monitoring respiratory effort might help to determine the added value of HFNO surrounding extubation. We hypothesize that HFNO, compared to conventional oxygen therapy (COT), prevents de-recruitment of the lung and reduces respiratory effort, and so provides a physiologic clarification for the reduction in the need for reintubation.

Objective: Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration.

Study design: A physiologic, randomized clinical study comparing two standard of clinical care therapies.

Study population: Adult patients on invasive mechanical ventilation (IMV) for >72 hours, who are scheduled for extubation.

Intervention (if applicable): Before extubation, patients are randomized to receive COT (reference group) or HFNO as oxygenation regimen after extubation.

Main study parameters/endpoints: The main outcome is the difference in change in lung respiratory muscle effort (mean ΔPES) at 24 hours post-extubation between the study groups. Secondary parameters are differences in changes in respiratory effort at 2 and 4 hours post-extubation, difference in change in lung aeration (mean ΔEELI), differences in tidal volume, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC, Rotterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged ≥ 18 years
  • Receiving IMV > 48 hours for any cause
  • Successfully completing spontaneous breathing trial (SBT) as per local clinical guideline
  • Provided written informed consent, through legal representatives on indication

Exclusion criteria

  • Any clinical situation preventing appropriate execution of study procedures
  • The presence of a tracheostomy
  • Any feature that precludes HFNO-initiation
  • Indication for NIV such as hypercapnia at end of SBT, or Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome with CPAP use in medical history
  • Contra-indication for nasogastric tube or inability to perform adequate PES measurements.
  • Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray and evidence of paralysis during ultrasound (i.e. paradoxal diaphragm movement during sniffing)
  • Known pregnancy or current breast-feeding

Treatment and study plan

High Flow Nasal Oxygen

Other

Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.

Other names: High Flow Nasal Cannula, Nasal High Flow Therapy

Conventional Oxygen Therapy

Other

Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols

Primary outcomes

  1. delta Esophageal Pressure (ΔPES)

    Time frame: At 24 hours after extubation

    The difference between groups in change in ΔPES in patients 24 hours post-extubation.

Secondary outcomes

  1. ΔPES

    Time frame: At 2 and 4 hours post-extubation

    The difference between groups in change in ΔPES after extubation

  2. delta global End-expiratory lung impedance (∆EELIglobal)

    Time frame: At 2, 4 and 24 hours after extubation

    Difference between the groups in change in mean ∆EELIglobal

  3. Pressure-time product of Esophageal Pressure (PTPES)

    Time frame: At 2,4 and 24 hours after extubation

    The difference between the groups in mean pressure-time product (PTPES) compared to baseline.

  4. EIT parameters

    Time frame: At 2, 4 and 24 hours after extubation

    ∆VARt, ∆EELIdependent, ∆EELInon-dependent compared to baseline (impedance on IMV).

  5. Global Inhomogeneity index

    Time frame: At 2, 4 and 24 hours after extubation

Other outcomes

  1. non-invasive positive pressure ventilation (NIPPV)

    Time frame: Within 7 days post-extubation

    Treatment escalation

  2. Continuous positive airway pressure (CPAP)

    Time frame: Within 7 days post-extubation

    Treatment escalation

  3. invasive mechanical ventilation (IMV).

    Time frame: Within 7 days post-extubation

    Treatment escalation

  4. Survival rate

    Time frame: Within 7 days post-extubation

    Survival rates

  5. Sputum

    Time frame: At 2 and 24 hours after extubation

    Difference in sputum aspect and sputum clearance between the study groups, assessed with a 5-point likert scale.

  6. Dyspnea score

    Time frame: At 2 and 24 hours after extubation

    Difference in dyspnea sensation between the groups, measured with Visual Analog Scale (VAS, ranging from 0 = No dyspnea until 10 = maximum dyspnea).

Sponsors and collaborators

Lead sponsor

Henrik Endeman

Other

Collaborators

  • Franciscus Gasthuis
  • Maasstad Hospital

Registry information

Official study title

High Flow Nasal Oxygen Therapy Re-evaluated from a Conceptual Point of View: Effect on Respiratory Effort and Lung Aeration After Extubation

Acronym: T-REX

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2022
Registry last updated
Jan 17, 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.

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