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

NCT05778682 | Unknown DMC

• 1 other identifier: 2022-4213
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Weaning

Outcome Measures

Primary Outcomes (1)

• Time to decannulation

  Time between the randomisation and the 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.

Secondary Outcomes (8)

• 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.

• Length of stay ICU

  From admission to the date when the patient quit the ICU, through study completion, average of 6 to 12 months.

• 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.

• ICU readmission

  Through study completion, average of 6 to 12 months.

• Decannulation failure

  Through study completion, average of 6 to 12 months.

Study Arms (2)

Suction based protocol

EXPERIMENTAL

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)

Procedure: Suctioning based protocol

Usual care

OTHER

Usual care will mainly base on the capping trial.

Procedure: Usual Care

Interventions

Suctioning based protocol PROCEDURE

cf. arm The necessity of suctioning will be assed continuously by the nurses, respiratory therapist and the medical team. If the patient require 2 or less aspiration each 8 hours for 24 hours straight, an attempt of decanalution will be done.

Suction based protocol

Usual Care PROCEDURE

Usual care in our center is tolerance to a capping trial.

Usual care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Related Publications (27)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None, patients and physicians will know the protocol
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 21, 2023
• Study Start: March 20, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)