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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new method to help ICU patients with breathing tubes breathe on their own. The new technique adjusts the cleaning schedule of their airways, compared to the usual method of seeing how long they can tolerate having their breathing tube closed. The goal is to find a more effective way to transition these patients from mechanical ventilation to independent breathing.

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 data supports the effectiveness of the treatment Suctioning based protocol, Usual Care, Standard Care, Conventional Care in the clinical trial titled 'Tracheostomy Weaning Protocol for Intensive Care Patients'?

Research suggests that using weaning protocols can help reduce the time patients spend on mechanical ventilation, which is a key part of the tracheostomy weaning process. This indicates that a structured approach, like a suctioning-based protocol, may be beneficial in managing tracheostomy patients in intensive care. ^{1 2 3 4 5}

Is the tracheostomy weaning protocol safe for humans?

Research shows that using a nurse-led weaning protocol for tracheostomized patients is feasible and safe compared to traditional methods based on a doctor's judgment. This suggests that the protocol is generally safe for humans. ^{1 2 5 6 7}

How does the Suctioning based protocol differ from usual care for tracheostomy weaning in intensive care patients?

The Suctioning based protocol is unique because it involves a structured approach to weaning patients from mechanical ventilation, potentially led by nurses, which contrasts with the usual care that relies on a physician's clinical judgment. This protocol aims to standardize the weaning process, which may improve efficiency and safety in tracheostomized patients. ^{1 2 5 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

An evaluation of protocolised weaning on the duration of mechanical ventilation. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Tracheostomy protocol: experience with development and potential utility. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Use of weaning protocols for reducing duration of mechanical ventilation in critically ill adult patients: Cochrane systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hospital and long-term outcome after tracheostomy for respiratory failure. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Comparison between a nurse-led weaning protocol and weaning based on physician's clinical judgment in tracheostomized critically ill patients: a pilot randomized controlled clinical trial. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Tracheostomy care and decannulation during the COVID-19 pandemic. A multidisciplinary clinical practice guideline. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Management of tracheostomy: a survey of Dutch intensive care units. [2015]

8. India pubmed.ncbi.nlm.nih.gov

Tracheostomy in Adult Intensive Care Unit: An ISCCM Expert Panel Practice Recommendations. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Factors influencing the implementation of a ventilation weaning protocol in an adult intensive care unit: a qualitative multidisciplinary evaluation. [2023]