Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)
Launched by CENTRE HOSPITALIER DE SAINT-DENIS · Jul 2, 2025
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This study is looking at how well patients who have a tracheostomy—a small tube placed in their windpipe to help with breathing—can cough before and after the tube is taken out. Coughing is important because it helps clear the airway and prevent infections. Researchers will use two different tools to measure cough strength and see if the measurements taken before removing the tube can predict how strong the cough will be afterward. They will also explore other factors that might affect coughing and ask patients how they feel about using these measurement devices. Additionally, the study will use ultrasound to look at the diaphragm (the main muscle used for breathing) to see if it helps predict cough strength.
Adults who are hospitalized in intensive care or rehabilitation units, have a tracheostomy during the process of weaning off breathing support, and have been prescribed physiotherapy and speech therapy assessments may be eligible to join. People who have had certain surgeries, severe swallowing problems, difficulty understanding instructions, or who choose not to participate will not be included. If you take part, you can expect to have your cough strength measured before and after the tracheostomy tube is removed, and to share your thoughts on the devices used. This study is not yet recruiting participants but aims to help doctors better understand and support patients recovering from tracheostomy.
Gender
ALL
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
About Centre Hospitalier De Saint Denis
The Centre Hospitalier de Saint-Denis is a leading healthcare institution dedicated to providing high-quality medical services and advancing clinical research. Located in Saint-Denis, France, the hospital is renowned for its commitment to patient-centered care, innovative treatments, and interdisciplinary collaboration. As a clinical trial sponsor, it actively engages in the development of new therapeutic options, striving to enhance patient outcomes through rigorous research protocols and adherence to ethical standards. With a focus on diverse medical disciplines, the Centre Hospitalier de Saint-Denis plays a pivotal role in contributing to the advancement of medical knowledge and the improvement of public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported