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

July 2, 2025 updated by: Centre Hospitalier de Saint-Denis
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Group - Cough Effort Measurement and Follow-Up
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.
Time Frame: From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.
From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Saint-Denis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2025

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 2, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0095_KINESITHERAPIE_LOST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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