Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Saint-Denis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device
DeviceThis 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.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Single Group - Cough Effort Measurement and Follow-UpOther 1 intervention
Trial outcomes
Primary outcomes
1
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: