Tracheostomy Weaning Protocol for Intensive Care Patients

(DECAP-ICU Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Severe dysphagia, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 to 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help patients in intensive care units remove tracheostomies, which are breathing tubes in the throat. Researchers compare a method based on how often patients need suctioning (removing mucus) with the usual method that assesses how long they can tolerate capping (closing off the tube). The trial aims to determine if the suctioning-based method leads to better outcomes. It targets individuals who have been off a ventilator for at least 24 hours and are in the process of removing the tracheostomy. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance recovery processes in intensive care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this weaning tracheostomy technique is safe for intensive care patients?

Research shows that a tracheostomy can increase patient comfort and simplify procedures like tube changes and suctioning compared to a breathing tube through the mouth or nose. Studies on the frequency of suctioning to determine when to remove the tracheostomy have shown positive results. This approach might reduce the time patients need the tracheostomy, indicating improved safety.

No reports have linked serious side effects directly to this suctioning-based method. Although researchers are still studying this treatment, the absence of major negative outcomes so far suggests it is well-tolerated. It is important to remember that this method remains under investigation, and further information will help confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to weaning patients off tracheostomy in intensive care. The suction-based protocol being tested differs from the usual care by focusing on the frequency of suctioning as a key indicator for readiness to remove the tracheostomy tube. This method aims to streamline the weaning process by using a high-flow nasal cannula and setting clear criteria for decannulation, potentially leading to faster recovery and shorter ICU stays compared to traditional capping trials.

What evidence suggests that this weaning protocol is effective for intensive care patients?

Research has shown that a suctioning method can shorten the time needed to remove a tracheostomy tube. In this trial, participants will follow either a suction-based protocol or usual care, which involves high-flow oxygen therapy with capping. The suctioning approach proved effective in successfully removing the breathing tube. Patients using this method experienced better outcomes, including less time on a ventilator. Additionally, many did not require reinsertion of the tube. These findings suggest that the suctioning method could lead to quicker recovery and shorter hospital stays for patients with tracheostomies in intensive care. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients in the ICU who have been weaned off mechanical ventilation for at least a day and are ready within 24 hours to try decannulation. It's not suitable for those with severe conditions like a high Sabadell score, low Glasgow Coma Scale, blocked airways, long-term tracheostomy needs, serious swallowing issues, or certain neuromuscular diseases.

Inclusion Criteria

Randomisation must be done within 24 hours of the mechanical ventilation weaning.

I have been off a breathing machine for at least 24 hours.

Exclusion Criteria

I do not have severe swallowing issues, a blocked airway, certain muscle diseases, or a long-term breathing tube in my neck.

Sabadell score > 2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a weaning tracheostomy technique based on suctioning frequency compared to standard capping tolerance

6 to 12 months

Follow-up

Participants are monitored for safety and effectiveness after decannulation

48 months

What Are the Treatments Tested in This Trial?

Interventions

• Suctioning based protocol
• Usual Care

Trial Overview The DECAP-ICU trial compares two methods of removing tracheostomy tubes: one based on how often suctioning is needed (new technique) versus the usual way which relies on how well patients tolerate having their tube capped.

How Is the Trial Designed?

Group I: Usual care Experimental Treatment 1 Intervention

Usual care will mainly base on the capping trial.

Group II: Suction based protocol Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05778682

Decannulation of Tracheostomy Cannula Based on ... 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 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2010834

High-Flow Oxygen with Capping or Suctioning for ... The primary outcome was the time to decannulation, compared by means of the log-rank test. Secondary outcomes included decannulation failure, ...

3. withpower.com withpower.com/trial/phase-tracheostomy-weaning-2-2023-9dd31

Tracheostomy Weaning Protocol for Intensive Care ... The Suctioning based protocol is unique because it involves a structured approach to weaning patients from mechanical ventilation, potentially led by nurses, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10644282/

Effectiveness of Minitracheostomy After Extubation in ... Among the patients who underwent mini-tracheostomy after extubation, 22 (71%) experienced successful extubation and 9 required reintubation. The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0964339725001375

Impact of tracheostomy on ICU stay in adult patients with ... Of the 1,074 patients with tracheostomy, 626 (58.3%) were successfully weaned from the ventilator. Mortality outcomes were documented in 18 studies, indicating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8029615/

Tracheotomy Outcomes in the Medical Intensive Care Unit Compared to intubation, tracheostomy is associated with increased patient comfort, increased ease of tube replacement and suctioning, and the ability to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05906888

Study Details | NCT05906888 | Weaning with Tracheostomy The present study aims to assess the duration of the weaning period, and the prevalence and severity of dyspnea and discomfort in patients with tracheostomy- ...