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

Completed

• Conditions: Tracheostomy Complication; Respiratory Failure

• Registration Number: NCT04987398
• Lead Sponsor: Piquilloud Imboden Lise

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Study First Submitted: 2021-07-12
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-03
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-15
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from intubation to tracheotomy	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 Outcome Measures

Name	Time	Method
Age	At ICU admission	Collected from electronic patient files.
Height	At ICU admission	Collected from electronic patient files.
Comorbidities	At ICU admission	Collected at ICU admission
Predicted body weight (PBW)	At ICU admission	Calculated as such : Adult male: 50 + 0.91 (Height cm -152.4) / Adult female: 45 + 0.91 (Height cm -152.4)
Sedation opioid use from intubation to tracheotomy	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.
Tracheotomy time	At time of tracheotomy, once, up to 60 days after intubation day	Collected from electronic patient files (day and hour)
Body mass index	At ICU admission	Calculated from weight and height
Opioid use from intubation to tracheotomy	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.
Weight	At ICU admission	Collected from electronic patient files.
SOFA score (admission)	At ICU admission	Calculated at admission
Clinical Frailty Score	At ICU admission	Calculated at ICU admission
Ventilation settings and modalities from day of tracheotomy	2 hours before tracheotomy	Collected from electronic patient files.
Physical therapy sessions from tracheotomy to mechanical ventilation weaning	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.
Hospital stay duration	Once, between day of hospital admission to day of hospital discharge, up to 2 years	Collected from electronic patient files and discharge letters
Charlson comorbidity index	At ICU admission	Calculated at ICU admission
SOFA score (mechanical ventilation weaning day)	Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day	Calcutated from electronic patient files.
Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death	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.
Outcome and specific treatments in ICU	Once, between day of hospital admission to day of hospital discharge, up to 2 years	Data recolted from electronic patient files
Ventilation modalities and settings from intubation to tracheotomy	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.
SOFA score (tracheotomy day)	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.
Mechanical ventilation weaning day	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.
Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death	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.
Neuromuscular blocking agent use from intubation to tracheotomy	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.
Tracheotomy type (percutaneous, surgical)	At time of tracheotomy, once, up to 60 days after intubation day	Collected from electronic patient files.
Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning	Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days	Ventilation modalities and settings collected from electronic patient files.
Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning	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.
Correlation of ventilation settings and modalities and tracheotomy weaning strategies	Once, between day of hospital admission to day of hospital discharge, up to 2 years	Collected from electronic patient files and discharge letters

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland