Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients

NCT ID: NCT07317791

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Decannulation Protocol Group

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

Group Type: EXPERIMENTAL

standardized tracheostomy decannulation protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hongying Jiang, MD

OTHER

Sponsor Role: lead

Responsible Party

Hongying Jiang, MD

Capital Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hongying Jiang, MD

Role: STUDY_CHAIR

Beijing Rehabilitation Hospital of Capital Medical University

Locations

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, China

Hunan Rehabilitation Hospital

Hunan, Hunan, China

Jiangbin Hospital of Guangxi Zhuang Autonomous Region

Guangxi, Jiangbin, China

YanBian University Hospital

Jilin, Yanbian, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Henan, Zhengzhou, China

Countries

China

Central Contacts

Jingyi Ge

Role: CONTACT

ge_jingyi2020@163.com

+861056981098

Facility Contacts

Hongying Jiang

Role: primary

6jhy@163.com

+861056981067

Pan Li

Role: primary

584703769@qq.com

18674765825

Li Zheng

Role: primary

819237886@qq.com

17776263283

Shenglan Jin

Role: primary

Shenglan91@163.com

04332660078

Yajing Wang

Role: primary

wangya568@163.com

86-15515645380

Other Identifiers

2025-hxkfzx-dzx-002

Identifier Type: -

Identifier Source: org_study_id