An interventional study of Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device in Tracheostomy, Cough and Weaning, sponsored by Centre Hospitalier de Saint-Denis. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Centre Hospitalier de Saint-Denis · Not applicable, Interventional, and Diagnostic
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 34 is below the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Centre Hospitalier de Saint-Denis is the lead sponsor of 45 studies on the registry; 19 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
No study locations are listed for this record.
Start is estimated for Jul 2025; primary completion for Nov 2026, 16 months later.
Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 16 months is close to that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Saint-Denis