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

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.

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Key information

Conditions

Tracheostomy Cough Diaphragm Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Function Tests Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Denis

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 11, 2025
Registry last updated: Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed