Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device.
- Who it may be relevant to
- Registry conditions: Tracheostomy, Cough, Weaning, Respiratory Function Tests. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07061561 · 0095_KINESITHERAPIE_LOST