Determinants of Successful Decannulation in Difficult-to-wean Patients

NCT04841889 | Completed DMC

• 1 other identifier: 2020-A03070-39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The factors of success of decannulation are not well known in the literature and the decision to decannulate is mainly based on clinical judgment. The failure rate of decannulation is between 2 and 25% with a poor prognosis in case of failure. The objective of this study is to determine the factors associated with successful tracheostomy removal in patients hospitalized in a respiratory weaning unit. The secondary objectives are to evaluate in tracheostomized and hospitalized patients in weaning unit:

• The prevalence of successful tracheostomy removal;
• The prevalence of successful weaning from mechanical ventilation;
• Factors associated with successful weaning from mechanical ventilation;
• Demographic characteristics of these patients at admission;
• Ventilatory characteristics of these patients at admission;
• Biological characteristics of these patients at admission; This is a prospective, single-centre, interventional cohort study with an expected duration of 2 years. All patients admitted to the respiratory weaning unit in the Forcilles' hospital, with a tracheostomy and an expected duration of mechanical ventilation \> 48 hours will be consecutively included. All factors potentially associated with successful tracheostomy removal will be prospectively collected: severity factors related to the ICU stay, ventilatory factors, respiratory and extra-respiratory factors.

Conditions

Tracheostomy; ICU; Weaning Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients successfully liberated from the tracheostomy

  Successful removal of the tracheostomy will be defined after 48 hours of spontaneous breathing without canulae. Acute use of mechanical or noninvasive ventilation, or death will be defined as failed tracheostomy removal.

  After 48 hours of spontaneous breathing

Secondary Outcomes (1)

• Proportion of patients successfully liberated from the ventilator

  After 48 hours of spontaneous breathing

Study Arms (1)

Associated factors with decannulation

OTHER

Collection of demographic, biological, ventilatory, respiratory and extra-respiratory parameters at the admission and the end of stay in the respiratory weaning center. Lung and diaphragm ultrasound, swallowing and muscles assessment will be performed.

Diagnostic Test: Associated factors with decannulation

Interventions

Associated factors with decannulation DIAGNOSTIC_TEST

All factors potentially associated with successful tracheostomy removal will be prospectively collected: severity factors related to the ICU stay, ventilatory factors, respiratory and extra-respiratory factors. Lung and diaphragm ultrasound, swallowing, muscles and functional assessment will be performed.

Associated factors with decannulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized in weaning unit
• Presence of a tracheostomy at admission;
• Expected duration of mechanical ventilation \>48h at admission;

You may not qualify if:

• Known pregnancy;
• Patient with protective measure of justice;
• Patient under guardianship or curators;
• Data access denial

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, 77150, France

Location

Study Officials

• PERETOUT Jean-Baptiste, MD

  Hôpital Forcilles-Fondation Cognacq-Jay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 12, 2021
• Study Start: April 15, 2021
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Data requesters must provide supporting documentation (e.g: research proposals) to the principal investigator. Request will be reviewed by the research committee of the sponsor.

Locations

FR (1)