Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study) (NCT07061561) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)
34 participantsStarted 2025-07-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.
Timeframe: From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.