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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987398
• Other study ID #: TRACH-CHANGE
• Status: Completed
• Start date: June 10, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: August 2021
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency
• Tracheostomy Complication

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Piquilloud Imboden Lise

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Andriolo BN, Andriolo RB, Saconato H, Atallah ÁN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015 Jan 12;1:CD007271. doi: 10.1002/14651858.CD007271.pub3. Review. — View Citation

Arabi Y, Haddad S, Shirawi N, Al Shimemeri A. Early tracheostomy in intensive care trauma patients improves resource utilization: a cohort study and literature review. Crit Care. 2004 Oct;8(5):R347-52. Epub 2004 Aug 23. Review. — View Citation

Béduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grangé S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Réseau Européen de Recherche en Ventilation Artificielle) Network ‡. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC. — View Citation

Burns KEA, Soliman I, Adhikari NKJ, Zwein A, Wong JTY, Gomez-Builes C, Pellegrini JA, Chen L, Rittayamai N, Sklar M, Brochard LJ, Friedrich JO. Trials directly comparing alternative spontaneous breathing trial techniques: a systematic review and meta-analysis. Crit Care. 2017 Jun 1;21(1):127. doi: 10.1186/s13054-017-1698-x. Review. — View Citation

Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. Review. — View 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. Review. — View 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. — View Citation

Young D, Harrison DA, Cuthbertson BH, Rowan K; TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013 May 22;309(20):2121-9. doi: 10.1001/jama.2013.5154. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from intubation to tracheotomy	Calculated from clinical information system (time of intubation, time of tracheotomy), calculated in hours	Once, between time of intubation to time of tracheotomy, up to 60 days
Secondary	Age	Collected from electronic patient files.	At ICU admission
Secondary	Weight	Collected from electronic patient files.	At ICU admission
Secondary	Height	Collected from electronic patient files.	At ICU admission
Secondary	Body mass index	Calculated from weight and height	At ICU admission
Secondary	Predicted body weight (PBW)	Calculated as such : Adult male: 50 + 0.91 (Height cm -152.4) / Adult female: 45 + 0.91 (Height cm -152.4)	At ICU admission
Secondary	SOFA score (admission)	Calculated at admission	At ICU admission
Secondary	Clinical Frailty Score	Calculated at ICU admission	At ICU admission
Secondary	Charlson comorbidity index	Calculated at ICU admission	At ICU admission
Secondary	Comorbidities	Collected at ICU admission	At ICU admission
Secondary	Ventilation modalities and settings from intubation to tracheotomy	Ventilation modalities and settings recolted from electronic patient files.	Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days
Secondary	Sedation opioid use from intubation to tracheotomy	Sedation use collected from electronic patient files.	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
Secondary	Opioid use from intubation to tracheotomy	Opioid use collected from electronic patient files.	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
Secondary	Neuromuscular blocking agent use from intubation to tracheotomy	Neuromuscular blocking agent use collected from electronic patient files.	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
Secondary	Tracheotomy time	Collected from electronic patient files (day and hour)	At time of tracheotomy, once, up to 60 days after intubation day
Secondary	Tracheotomy type (percutaneous, surgical)	Collected from electronic patient files.	At time of tracheotomy, once, up to 60 days after intubation day
Secondary	Ventilation settings and modalities from day of tracheotomy	Collected from electronic patient files.	2 hours before tracheotomy
Secondary	SOFA score (tracheotomy day)	Calculated from electronic patient files.	Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day
Secondary	Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning	Ventilation modalities and settings collected from electronic patient files.	Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days
Secondary	Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning	Data collected from electronic patient files.	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
Secondary	Physical therapy sessions from tracheotomy to mechanical ventilation weaning	Data collected from electronic patient files.	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
Secondary	Mechanical ventilation weaning day	Data collected from electronic patient files.	Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day
Secondary	SOFA score (mechanical ventilation weaning day)	Calcutated from electronic patient files.	Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day
Secondary	Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death	Collected from electronic patient files.	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
Secondary	Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death	Collected from electronic patient files.	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
Secondary	Hospital stay duration	Collected from electronic patient files and discharge letters	Once, between day of hospital admission to day of hospital discharge, up to 2 years
Secondary	Outcome and specific treatments in ICU	Data recolted from electronic patient files	Once, between day of hospital admission to day of hospital discharge, up to 2 years
Secondary	Correlation of ventilation settings and modalities and tracheotomy weaning strategies	Collected from electronic patient files and discharge letters	Once, between day of hospital admission to day of hospital discharge, up to 2 years