Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06642714
NA

Standardized Tracheostomy Weaning Protocol for Prolonged Mechanical Ventilation

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

This study evaluated the feasibility and clinical outcomes of a standardized weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. The protocol was delivered in a specialized weaning unit of a tertiary rehabilitation hospital and combined early noninvasive ventilation, progressive high-flow oxygen therapy through the tracheostomy tube, spontaneous breathing trials when appropriate, and stepwise reduction of ventilatory support. The main outcome was successful liberation from mechanical ventilation within 60 days.

Official title: Early Noninvasive Ventilation and Progressive High-Flow Oxygen Therapy Through a Tracheostomy Tube Weaning Protocol in Tracheostomized Patients With Prolonged Mechanical Ventilation: A Prospective Single-Arm Interventional Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-01-01

Completion Date

2026-03-30

Last Updated

2026-05-28

Healthy Volunteers

No

Interventions

OTHER

Standardized Stepwise Weaning Protocol

The intervention was a standardized stepwise weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. Clinical stability and readiness for weaning were assessed before protocol initiation. Ventilator support was gradually reduced according to patient tolerance. When patients met predefined readiness criteria, spontaneous breathing trials were performed under pressure support ventilation. Patients who tolerated spontaneous breathing trials transitioned to progressively longer periods of high-flow oxygen therapy delivered through the tracheostomy tube. Noninvasive ventilation was used when appropriate to support transition from invasive ventilation and facilitate liberation from ventilatory support. Patients were reconnected to the ventilator if signs of respiratory distress or clinical instability occurred. Airway clearance, rehabilitation, nutritional support, and multidisciplinary reassessment were integrated throughout the protocol.

Locations (1)

Beijing Rehabilitation Hospital of Capital Medical University

Beijing, China