What side effects are associated with this type of intervention?

Common side effects associated with tracheostomy weaning techniques, including those based on suctioning frequency, often involve infection at the tracheostomy site, bleeding, airway obstruction, and the formation of granulation tissue. Frequent suctioning, a key component of managing secretions and maintaining airway patency, can also cause mucosal damage, bleeding, and patient discomfort. These complications necessitate careful monitoring and management to ensure patient safety and comfort during the weaning process.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for tracheostomy weaning techniques based on suctioning frequency. Generally, tracheostomy management involves the use of suctioning devices, humidification systems, and sometimes mucolytic agents to manage secretions and maintain airway patency. These methods are standard practice in clinical settings to facilitate weaning from tracheostomy.

What other types of research exist?

Promising alternatives to the New Weaning Tracheostomy Technique based on suctioning frequency include: 1) High-flow oxygen therapy, which can improve oxygenation and reduce the need for suctioning by maintaining airway patency. 2) Mechanical insufflation-exsufflation devices, which assist in secretion clearance by simulating a cough. 3) Oscillatory positive expiratory pressure (OPEP) devices, which enhance mucus clearance through airway oscillation. 4) Intrapulmonary percussive ventilation, which combines high-frequency oscillations with positive pressure to mobilize secretions. These methods have shown potential in improving secretion management and facilitating tracheostomy weaning.

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Tracheostomy Weaning Protocol for Intensive Care Patients (DECAP-ICU Trial)

N/A

Waitlist Available

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 6 to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort during suctioning or capping procedures, breathing difficulties after removal of the tube, infection risk at the site of the tracheostomy cannula, and possible need for reinsertion if decannulation fails.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from admission to the date when the patient quit the icu, through study completion, average of 6 to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from admission to the date when the patient quit the icu, through study completion, average of 6 to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from admission to the date when the patient quit the icu, through study completion, average of 6 to 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to decannulation

Secondary study objectives

Adverses effects

Decannulation failure

ICU readmission

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual careExperimental Treatment1 Intervention

Usual care will mainly base on the capping trial.

Group II: Suction based protocolExperimental Treatment1 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for tracheostomy weaning focus on managing secretions and maintaining airway patency. Techniques like frequent suctioning are crucial as they help remove secretions, preventing airway obstruction and reducing the risk of respiratory infections. This is particularly important for tracheostomy weaning patients as it ensures a clear airway, facilitating a gradual reduction in dependence on the tracheostomy tube. This method is being studied in the new weaning tracheostomy technique based on suctioning frequency, which contrasts with the standard practice of capping tolerance. Both approaches aim to ensure a safe and effective transition from mechanical ventilation to spontaneous breathing.