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Completed

NCT Number: NCT04987398

Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Lausanne ICU

This retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Tracheostomy Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients hospitalized in the Lausanne ICU between May 1st 2017 and November 31st 2018 with a tracheotomy and mechanically ventilated more than 72 hours.

Exclusion criteria

  • Presence of a know opposition to participation to research projects
  • Patient tracheostomized specifically for ENT (ear-nose-throat) reason
  • Burn victim
  • Patient tracheostomized before his/her admission to the Lausanne ICU

Treatment and study plan

Primary outcomes

  1. Time from intubation to tracheotomy

    Time frame: Once, between time of intubation to time of tracheotomy, up to 60 days

    Calculated from clinical information system (time of intubation, time of tracheotomy), calculated in hours

Secondary outcomes

  1. Age

    Time frame: At ICU admission

    Collected from electronic patient files.

  2. Weight

    Time frame: At ICU admission

    Collected from electronic patient files.

  3. Height

    Time frame: At ICU admission

    Collected from electronic patient files.

  4. Body mass index

    Time frame: At ICU admission

    Calculated from weight and height

  5. Predicted body weight (PBW)

    Time frame: At ICU admission

    Calculated as such :

    Adult male: 50 + 0.91 (Height cm -152.4) / Adult female: 45 + 0.91 (Height cm -152.4)

  6. SOFA score (admission)

    Time frame: At ICU admission

    Calculated at admission

  7. Clinical Frailty Score

    Time frame: At ICU admission

    Calculated at ICU admission

  8. Charlson comorbidity index

    Time frame: At ICU admission

    Calculated at ICU admission

  9. Comorbidities

    Time frame: At ICU admission

    Collected at ICU admission

  10. Ventilation modalities and settings from intubation to tracheotomy

    Time frame: Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days

    Ventilation modalities and settings recolted from electronic patient files.

  11. Sedation opioid use from intubation to tracheotomy

    Time frame: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days

    Sedation use collected from electronic patient files.

  12. Opioid use from intubation to tracheotomy

    Time frame: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days

    Opioid use collected from electronic patient files.

  13. Neuromuscular blocking agent use from intubation to tracheotomy

    Time frame: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days

    Neuromuscular blocking agent use collected from electronic patient files.

  14. Tracheotomy time

    Time frame: At time of tracheotomy, once, up to 60 days after intubation day

    Collected from electronic patient files (day and hour)

  15. Tracheotomy type (percutaneous, surgical)

    Time frame: At time of tracheotomy, once, up to 60 days after intubation day

    Collected from electronic patient files.

  16. Ventilation settings and modalities from day of tracheotomy

    Time frame: 2 hours before tracheotomy

    Collected from electronic patient files.

  17. SOFA score (tracheotomy day)

    Time frame: Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day

    Calculated from electronic patient files.

  18. Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning

    Time frame: Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days

    Ventilation modalities and settings collected from electronic patient files.

  19. Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning

    Time frame: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days

    Data collected from electronic patient files.

  20. Physical therapy sessions from tracheotomy to mechanical ventilation weaning

    Time frame: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days

    Data collected from electronic patient files.

  21. Mechanical ventilation weaning day

    Time frame: Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day

    Data collected from electronic patient files.

  22. SOFA score (mechanical ventilation weaning day)

    Time frame: Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day

    Calcutated from electronic patient files.

  23. Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death

    Time frame: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days

    Collected from electronic patient files.

  24. Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death

    Time frame: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days

    Collected from electronic patient files.

  25. Hospital stay duration

    Time frame: Once, between day of hospital admission to day of hospital discharge, up to 2 years

    Collected from electronic patient files and discharge letters

  26. Outcome and specific treatments in ICU

    Time frame: Once, between day of hospital admission to day of hospital discharge, up to 2 years

    Data recolted from electronic patient files

  27. Correlation of ventilation settings and modalities and tracheotomy weaning strategies

    Time frame: Once, between day of hospital admission to day of hospital discharge, up to 2 years

    Collected from electronic patient files and discharge letters

Sponsors and collaborators

Lead sponsor

Piquilloud Imboden Lise

Other

Registry information

Official study title

Analysis of Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Intensive Care Unit of the Lausanne University Hospital

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
Jun 3, 2022

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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