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

Comparison of Speaking Valve Trial Versus Capping Trial in the Decannulation Process for Patients With Prolonged Disorders of Consciousness: A Randomized Controlled Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prolonged Disorders of Consciousness
• Intervention / Treatment: Other: Speaking Valve Trial; Other: Capping Trial

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.

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• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100043
      • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decannulation rate	Proportion passing full protocol	At decannulation
Decannulation success rate	(Decannulation - Decannulation failure ) / Decannulation	At 48 h post decannulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to decannulation	Days from randomization to successful tube removal	1year
Hospital stay duration	Days from randomization to discharge without tracheostomy care	Up to 6 months
CRS-R change rate	(Post-decannulation score - Baseline)/Baseline	3 months
Airway safety score1	Pulse oxygen saturation (SpO₂) fluctuation, minimum value0%, maximum value 100%, the larger the value, the better the result	48h post-decannulation
Airway safety score 2	Blood carbon dioxide partial pressure (pCO₂) , normal range 35-45mmHg. Within the normal range it is good, the greater the deviation from the normal range, the worse the result the larger the value, the better the result.	48h post-decannulation

Collaborators and Investigators

• Sponsor: Hongying Jiang, MD
• Collaborators: Beijing Tiantan Hospital; Beijing Rehabilitation Hospital; Hunan Provincial Rehabilitation Hospital; Beijing Fengtai Rehabilitation Hospital
• Investigators: Study Chair: Hongying Jiang, Beijing Rehabilitation Hospital, Capital Medical University, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 4, 2025
• First Submitted That Met QC Criteria: September 11, 2025
• First Posted (Actual): September 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Decannulation; Prolonged disorders of consciousness; Speaking wave; Capping
• Other Study ID Numbers: 2025-hxkf-s&tc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No