TracheostomyNCT07061561
Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)
A study testing Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device in people with Tracheostomy and Cough, run by Centre Hospitalier de Saint-Denis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Cough, Weaning
- What is being tested?
- Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this 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.
- Conditions
- Tracheostomy, Cough, Weaning, Respiratory Function Tests, Diaphragm
- Being tested
- Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group - Cough Effort Measurement and Follow-Up | Other | Not described Receives: Device: Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.
Measured: From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061561
- Sponsor's protocol ID
- 0095_KINESITHERAPIE_LOST
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)
- ClinicalTrials.gov ID
- NCT07061561
- Acronym / sponsor ID
- 0095_KINESITHERAPIE_LOST
- Conditions
- Tracheostomy, Cough, Weaning, Respiratory Function Tests, Diaphragm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group - Cough Effort Measurement and Follow-Up | Other | Device: Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio 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. | Device | Single Group - Cough Effort Measurement and Follow-Up |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device in people with Tracheostomy and Cough, run by Centre Hospitalier de Saint-Denis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.