Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness

NCT ID: NCT07173634

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-02-01

Brief Summary

To assess whether the speaking valve trial, when employed as an indicator for extubation during the removal of tracheostomy tubes in patients with chronic consciousness disorder, provides superior benefits and heightened sensitivity relative to the conventional capping trial, thereby enhancing the overall extubation process.

Detailed Description

Patients with chronic consciousness disorder who require long-term mechanical ventilation and airway protection commonly undergo tracheostomy. However, tracheostomy tubes can cause inflammation, stenosis, excessive coughing, and swallowing dysfunction. Removing the tracheostomy tube, or extubation, can prevent long-term complications such as tracheal stenosis, tracheomalacia, vocal cord injury, and accidental extubation. Additionally, it enhances patient comfort, appearance, swallowing function, communication ability, and social integration. Therefore, for clinically stable patients with chronic consciousness disorder who can breathe spontaneously, have effective cough reflexes, and are capable of protecting their airways, early tube removal is advisable.In current extubation protocols, the capping trial is predominantly used to assess whether patients can tolerate tracheostomy tube removal. There have also been reports of studies using speaking valves as an alternative to the capping trial, but no direct comparison has been made between the two methods. Patients who can tolerate capping for 24 hours are generally considered suitable for tracheostomy tube removal. A speaking valve is a one-way valve placed at the end of the tracheostomy tube that directs airflow to the upper airway when the cuff is deflated. Studies have found that patients undergoing speaking valve training benefit in terms of vital signs, airway secretions, sense of smell, weaning from mechanical ventilation, post-tracheostomy extubation, hospital stay duration, and quality of life. However, it remains unclear whether this method can improve the success rate of extubation assessment in patients with chronic consciousness disorder. This study compares speaking valve training and the traditional capping trial in post-tracheostomy patients with chronic consciousness disorder, evaluating differences in extubation tolerance, extubation success rate, time to extubation, hospital stay duration, and improvement in consciousness levels.

Parazacco spilurus subsp. spilurus

Conditions

Prolonged Disorders of Consciousness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Speaking Valve (SV) Group

Stepwise speaking valve tolerance: 0.5h → 1h → 2h → 4h. Decannulation if: Tolerates a 4-hour speaking valve trial with pulse oxygen saturation (SpO₂) ≥ 95%, breathing rate (RR) \< 20/min, and no signs of distress during the 4-hour trial.

Group Type: EXPERIMENTAL

Speaking Valve Trial

Intervention Type: OTHER

The speaking valve group ascertains a patient's eligibility for decannulation following the results of the speaking valve test. A patient who can endure a 4-hour trial with a speaking valve, maintaining a pulse oxygen saturation (SpO₂) of at least 95%, a breathing rate (RR) below 20 per minute, and exhibiting no signs of distress throughout the trial, qualifies for decannulation.

Capping Group

Gradual capping: 1 hour → 4 hours → 6 hours → 12 hours → 24 hours → 48 hours. Decannulation if: Tolerates 48 hours of capping with SpO₂ ≥95%, respiratory rate (RR) \<20/min, and no distress during the 48-hour trial.

Group Type: ACTIVE_COMPARATOR

Capping Trial

Intervention Type: OTHER

The capping valve group determines a patient's eligibility for decannulation based on the results of the capping test. A patient who can tolerate 48 hours of capping with a pulse oxygen saturation (SpO₂) of ≥95%, a breathing rate (RR) of \<20/min, and no signs of distress during the 48-hour trial, is eligible for decannulation.

Interventions

Speaking Valve Trial

The speaking valve group ascertains a patient's eligibility for decannulation following the results of the speaking valve test. A patient who can endure a 4-hour trial with a speaking valve, maintaining a pulse oxygen saturation (SpO₂) of at least 95%, a breathing rate (RR) below 20 per minute, and exhibiting no signs of distress throughout the trial, qualifies for decannulation.

Intervention Type: OTHER

Capping Trial

The capping valve group determines a patient's eligibility for decannulation based on the results of the capping test. A patient who can tolerate 48 hours of capping with a pulse oxygen saturation (SpO₂) of ≥95%, a breathing rate (RR) of \<20/min, and no signs of distress during the 48-hour trial, is eligible for decannulation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults (18-80 years) with tracheostomy

2. Prolonged DoC (>28 days) confirmed by CRS-R score >0

3. Ventilator-free >48h

4. PaCO₂ <60 mmHg

5. PCF ≥100 L/min

6. No sepsis/organ failure

7. Controlled pulmonary infection

8. Written informed consent by legal representative

Exclusion Criteria

1. Intolerance to cuff deflation:

2. SpO₂ <93% on O₂ supplementation OR Respiratory rate >20/min for >5min

3. Severe tracheal stenosis (>50% lumen occlusion on CT)

4. Death within 2 weeks post-enrollment

5. Participation in conflicting interventional trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Hongying Jiang

OTHER

Sponsor Role: lead

Responsible Party

Hongying Jiang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hongying Jiang

Role: STUDY_CHAIR

Beijing Rehabilitation Hospital, Capital Medical University, Beijing

Central Contacts

Qian Feng

Role: CONTACT

fengqian0263@163.com

17207122873

Hongying Jiang

Role: CONTACT

6jhy@163.com

+8656981555

Other Identifiers

2025-hxkf-s&tc

Identifier Type: -

Identifier Source: org_study_id