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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07061561
Enrollment
34
Registered
2025-07-11
Start date
2025-07-15
Completion date
2026-11-15
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Diaphragm, Respiratory Function Tests, Tracheostomy, Weaning

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.

Interventions

DEVICEPeak 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.

Sponsors

Centre Hospitalier de Saint-Denis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026