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

NCT07061561 | Not Yet Recruiting

• 1 other identifier: 0095_KINESITHERAPIE_LOST
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.

  From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.

Study Arms (1)

Single Group - Cough Effort Measurement and Follow-Up

OTHER

Device: Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device

Interventions

Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device 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.

Single Group - Cough Effort Measurement and Follow-Up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years or older)
• Hospitalized in post-intensive care rehabilitation unit (SRPR) or intensive care unit (ICU)
• Tracheotomized during the weaning process
• Medical prescription for physiotherapy assessment
• Medical prescription for speech therapy assessment

You may not qualify if:

• Patients who have undergone total laryngectomy
• Patients with severe swallowing disorders
• Patients with cognitive impairments incompatible with understanding instructions
• Patients under medical decision to stop active treatments
• Patients who refuse to participate or refuse to sign informed consent
• Patients under guardianship or curatorship
• Patients not affiliated with a social security scheme

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07