Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients

January 17, 2026 updated by: Hongying Jiang, MD

Multicenter Prospective Validation of Cough Flow With Tracheostomy Tube and Speaking Valve (CFsv) >100 L/Min as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100043
        • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
        • Contact:
          • Hongying Jiang
          • Phone Number: +861056981067
          • Email: 6jhy@163.com
    • Hunan
      • Hunan, Hunan, China, 410000
        • Hunan Rehabilitation Hospital
        • Contact:
    • Jiangbin
      • Guangxi, Jiangbin, China, 530012
        • Jiangbin Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
    • Yanbian
      • Jilin, Yanbian, China, 133000
        • Yanbian University Hospital
        • Contact:
    • Zhengzhou
      • Henan, Zhengzhou, China, 450007
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decannulation Protocol Group
all patients included in the study will undergo standardized decannulation assessment.
Other: standardized tracheostomy decannulation protocol

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decannulation Success
Time Frame: 48 hours post-decannulation
No requirement for tracheostomy tube reinsertion within 48 hours after decannulation
48 hours post-decannulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongying Jiang, MD

Investigators

  • Study Chair: Hongying Jiang, MD, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-hxkfzx-dzx-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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