Clinical trial NCT04987398: Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Lausanne ICU
Official title: Analysis of Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Intensive Care Unit of the Lausanne University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Tracheostomy Complication
Keywords: Tracheostomy
Ventilation weaning
spontaneous breathing trial
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the Lausanne ICU between May1st and November 31st who had a tracheotomy and were ventilated for more than 72 hours were screened for exclusion criterias. 147 patients were screened and 80 patients were included.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from intubation to tracheotomy
timeFrame: Once, between time of intubation to time of tracheotomy, up to 60 days
Secondary outcomes:
measure: Age
timeFrame: At ICU admission
measure: Weight
timeFrame: At ICU admission
measure: Height
timeFrame: At ICU admission
measure: Body mass index
timeFrame: At ICU admission
measure: Predicted body weight (PBW)
timeFrame: At ICU admission
measure: SOFA score (admission)
timeFrame: At ICU admission
measure: Clinical Frailty Score
timeFrame: At ICU admission
measure: Charlson comorbidity index
timeFrame: At ICU admission
measure: Comorbidities
timeFrame: At ICU admission
measure: Ventilation modalities and settings from intubation to tracheotomy
timeFrame: Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days
measure: Sedation opioid use from intubation to tracheotomy
timeFrame: 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
measure: Opioid use from intubation to tracheotomy
timeFrame: 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
measure: Neuromuscular blocking agent use from intubation to tracheotomy
timeFrame: 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
measure: Tracheotomy time
timeFrame: At time of tracheotomy, once, up to 60 days after intubation day
measure: Tracheotomy type (percutaneous, surgical)
timeFrame: At time of tracheotomy, once, up to 60 days after intubation day
measure: Ventilation settings and modalities from day of tracheotomy
timeFrame: 2 hours before tracheotomy
measure: SOFA score (tracheotomy day)
timeFrame: Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day
measure: Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning
timeFrame: Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days
measure: Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning
timeFrame: 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
measure: Physical therapy sessions from tracheotomy to mechanical ventilation weaning
timeFrame: 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
measure: Mechanical ventilation weaning day
timeFrame: Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day
measure: SOFA score (mechanical ventilation weaning day)
timeFrame: Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day
measure: Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death
timeFrame: 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
measure: Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death
timeFrame: 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
measure: Hospital stay duration
timeFrame: Once, between day of hospital admission to day of hospital discharge, up to 2 years
measure: Outcome and specific treatments in ICU
timeFrame: Once, between day of hospital admission to day of hospital discharge, up to 2 years
measure: Correlation of ventilation settings and modalities and tracheotomy weaning strategies
timeFrame: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
References:
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citation: McCredie VA, Alali AS, Scales DC, Adhikari NK, Rubenfeld GD, Cuthbertson BH, Nathens AB. Effect of Early Versus Late Tracheostomy or Prolonged Intubation in Critically Ill Patients with Acute Brain Injury: A Systematic Review and Meta-Analysis. Neurocrit Care. 2017 Feb;26(1):14-25. doi: 10.1007/s12028-016-0297-z.
citation: Mehta AB, Walkey AJ, Curran-Everett D, Douglas IS. One-Year Outcomes Following Tracheostomy for Acute Respiratory Failure. Crit Care Med. 2019 Nov;47(11):1572-1581. doi: 10.1097/CCM.0000000000003959.
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