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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05778682
Acronym
DECAP-ICU
Enrollment
50
Registered
2023-03-21
Start date
2023-03-20
Completion date
2025-02-01
Last updated
2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomy Weaning

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.

Interventions

PROCEDURESuctioning based protocol

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.

PROCEDUREUsual Care

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

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

None, patients and physicians will know the protocol

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to decannulationFrome 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

MeasureTime frameDescription
Length of stay ICUFrom 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.
Length of stay hospitalFrom 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
ICU readmissionThrough study completion, average of 6 to 12 months.ICU readmission
Time to decannulation criteriaFrom 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
Mechanical Ventilation weaning failureThrough study completion, average of 6 to 12 months.Necessity of starting mechanical ventilation once the randomisation is started
Adverses effectsThrough study completion, average of 6 to 12 months.Pneumonia, sepsis, septic shock
MortalityThrough study completion, average of 6 to 12 months.All cause mortality
Decannulation failureThrough study completion, average of 6 to 12 months.Necessity of reimplantation of a tracheostomy after the decannulation

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026