NCT07317791

Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients

Not yet recruiting NA Last updated 21 January 2026

What this trial tests

NA trial testing standardized tracheostomy decannulation protocol in Tracheostomy in 500 participants. Not yet recruiting.

Timeline

1 January 2026

Primary endpoint
31 December 2026

30 September 2027

Quick facts

Lead sponsor	Hongying Jiang, MD
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	500
Start date	1 January 2026
Primary completion	31 December 2026
Estimated completion	30 September 2027
Sites	5 locations across China

Drugs / interventions tested

• standardized tracheostomy decannulation protocol

Conditions studied

• Tracheostomy — all drugs for Tracheostomy →

Sponsor

Hongying Jiang, MD

Who can join

Adults 18 to 90, any sex, with Tracheostomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.