Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness (SPEAK-CAP)

Hongying Jiang

Status: Not yet enrolling

Conditions: Prolonged Disorders of Consciousness

Treatments: Other: Capping Trial; Other: Speaking Valve Trial

Study type: Interventional

Funder types: Other

Identifiers

NCT07173634

2025-hxkf-s&tc

Details and patient eligibility

About

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.

Full 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

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Speaking Valve (SV) Group

Experimental group

Description:

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.

Treatment:

Other: Speaking Valve Trial

Capping Group

Active Comparator group

Description:

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.

Treatment:

Other: Capping Trial