NCT07061561

Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Centre Hospitalier de Saint-Denis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate how well tracheotomized patients can cough before and after their tracheostomy tube is removed. Cough strength is measured using two different tools-Peak Flow and Lorio. Researchers want to find out if the cough measurement taken before removing the tube can help predict how effective the patient's cough will be afterward. The study will also explore factors that might influence cough strength and compare the usefulness of the two tools. Additionally, it will assess how patients feel about using these devices and the role of diaphragm ultrasound in predicting cough effectiveness.

Conditions

• Tracheostomy
• Cough
• Weaning
• Respiratory Function Tests
• Diaphragm

Interventions

Type	Name	Description
DEVICE	Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device	This intervention involves the use of two respiratory measurement devices to assess cough strength in tracheotomized patients: the traditional Peak Flow meter, which measures peak expiratory flow (PEF), and the Lorio device, a novel tool designed for respiratory rehabilitation with customizable training exercises. Measurements are taken at multiple time points before and after decannulation to compare accuracy, reproducibility, and patient usability.

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-11-15
• Completion: 2026-11-15
• First posted: 2025-07-11
• Last updated: 2025-07-11