Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients

NCT07317791 | Not Yet Recruiting DMC

• 1 other identifier: 2025-hxkfzx-dzx-002
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 5

Brief Summary

Background: International studies have proposed a cough peak flow (CPF) of ≥160 L/min as a reference threshold for safe decannulation. However, this measurement requires prior removal of the tracheostomy tube, which is often difficult for Chinese patients and their families to accept due to cultural and safety concerns. Additionally, there is a lack of rapid, user-friendly, and widely applicable quantitative tools in clinical practice within ICUs or rehabilitation specialties in China. Moreover, the heterogeneity among domestic patient populations with different underlying conditions (such as neuromuscular diseases, spinal cord injuries, stroke, and respiratory failure) makes it challenging to apply a single foreign-derived indicator. In our center's prospective study from 2019 to 2022(Respiratory Research 2024;25:128), the investigators proposed and preliminarily validated that a cough flow measured with tracheostomy tube and speaking valve (CFSV) \>100 L/min could serve as a threshold for safe decannulation. Among 193 patients with long-term tracheostomy tubes, 105 were decannulated based on this threshold, with a success rate of 98.1%. Only two cases required reintubation within 48 hours (1.9%), and the six-month reintubation rate was 2.9%, which is significantly better than previously reported domestic and international data (reintubation rates of 5-15%). For patients with insufficient CFSV, after an average of 26 days of individualized cough enhancement rehabilitation, 91% achieved the threshold and ultimately succeeded in decannulation. This suggests that 100 L/min may be a more physiologically appropriate threshold for Chinese (and even East Asian) populations with indwelling tracheostomy tubes, and that CFSV combined with systematic rehabilitation interventions can significantly improve decannulation rates. However, these conclusions are derived from single-center data with a limited sample size, and the diversity of diseases and regional variations in medical standards may affect generalizability. Therefore, there is an urgent need for multicenter, large-sample prospective studies to validate the effectiveness, accuracy, and feasibility of CFSV \>100 L/min as a quantitative standard for safe decannulation.

Conditions

Tracheostomy

Keywords

Decannulation; Cough peak flow

Outcome Measures

Primary Outcomes (1)

• Decannulation Success

  No requirement for tracheostomy tube reinsertion within 48 hours after decannulation

  48 hours post-decannulation

Study Arms (1)

Decannulation Protocol Group

EXPERIMENTAL

all patients included in the study will undergo standardized decannulation assessment.

Other: standardized tracheostomy decannulation protocol

Interventions

standardized tracheostomy decannulation protocol OTHER

Step 1: Confirm that the patient is clinically stable. Step 2: Speaking valve (SV) with transtracheal end-expiratory pressure (TTPEE) measurement. Step 3: Measure the CFsv. Step 4: Continue wearing the SV for 4 hours. During this period, suctioning is not performed via the tracheostomy tube. Step 5: Assess readiness for decannulation. The CFsv is measured again prior to decannulation. If the value exceeds 100 L/min, decannulation is performed.

Decannulation Protocol Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Tracheostomy tube in place for ≥14 days
• Weaned from ventilator for more than 48 hours, or in a state of spontaneous breathing
• Patient and family members have provided informed consent

You may not qualify if:

• Severe craniofacial deformity preventing CFsv measurement
• Known obstructive upper airway pathology precluding tracheostomy tube removal
• Laryngopharyngeal trauma
• Inability to tolerate cuff deflation

Sponsors & Collaborators

• Hongying Jiang, MD: lead

Study Sites (5)

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, 100043, China

Location

Hunan Rehabilitation Hospital

Hunan, Hunan, 410000, China

Location

Jiangbin Hospital of Guangxi Zhuang Autonomous Region

Guangxi, Jiangbin, 530012, China

Location

YanBian University Hospital

Jilin, Yanbian, 133000, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Henan, Zhengzhou, 450007, China

Location

Study Officials

• Hongying Jiang, MD

  Beijing Rehabilitation Hospital of Capital Medical University

  STUDY CHAIR

Central Study Contacts

Jingyi Ge

CONTACT

+861056981098; ge_jingyi2020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Capital Medical University

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-12

Locations

CN (5)