Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit

Not Applicable

Not yet recruiting

• Conditions: Tracheostomy Weaning
• Interventions: Procedure: Suctioning based protocol; Procedure: Usual Care

• Registration Number: NCT05778682
• Lead Sponsor: Université de Sherbrooke

Brief Summary

In the DECAP-ICU trial, the investigators will be focusing on the impact of a new weaning tracheostomy technique based on suctioning frequency compared to the standard practice of capping tolerance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-16
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study Start: 2023-03-20
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2024-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Weaning from mechanical ventilation for at least 24 hours
• Randomisation must be done in 24 hours of the mechanical ventilation weaning.

Exclusion Criteria

• Sabadell > 2
• Contraindication of decannulation : Glasgow Coma Scale <6, severe dysphagia, non permeable respiratory tracks, neuromuscular disease (expect for the ICU weakness) and long term tracheostomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suction based protocol	Suctioning based protocol	Weaning protocol based on suctioning frequency. Once the weaning of mechanical ventilation, the patients in this arm will be on high-flow nasal canula. The canula will be remove if the decannulation conditions are met (if the patient require less than 2 aspirations in 8 hours for 24 consecutive hours)
Usual care	Usual Care	Usual care will mainly base on the capping trial.

Primary Outcome Measures

Name	Time	Method
Time to decannulation	Frome date of randomisation to the date of the actual decannulation or to the date of death, whichever comes first, assessed up to 48 months.	Time between the randomisation and the decannulation

Secondary Outcome Measures

Name	Time	Method
Time to decannulation criteria	From date of randomisation to the date when the criteria of decannulation are met or to the date of death, whichever comes first, assessed up to 48 months.	Time between the randomisation and the criteria of decannulation
Length of stay hospital	From admission to the date when the patient is discharge of the hospital, through study completion, average of 6 to 12 months.	Length of stay in the hospital
Length of stay ICU	From admission to the date when the patient quit the ICU, through study completion, average of 6 to 12 months.	Lenght of stay in the ICU.
ICU readmission	Through study completion, average of 6 to 12 months.	ICU readmission
Decannulation failure	Through study completion, average of 6 to 12 months.	Necessity of reimplantation of a tracheostomy after the decannulation
Mechanical Ventilation weaning failure	Through study completion, average of 6 to 12 months.	Necessity of starting mechanical ventilation once the randomisation is started
Adverses effects	Through study completion, average of 6 to 12 months.	Pneumonia, sepsis, septic shock
Mortality	Through study completion, average of 6 to 12 months.	All cause mortality

Trial Locations

Locations (1)

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada