Evaluating diaphragmatic dysfunction after non-intubated thoracic surgery
Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.
This study is testing how often patients experience diaphragm problems after having non-intubated thoracic surgery to see if their breathing is affected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Quincy-sous-Sénart) |
| Trial ID | NCT06486168 on ClinicalTrials.gov |
What this trial studies
This prospective longitudinal study aims to assess the incidence of diaphragmatic dysfunction in patients undergoing non-intubated video-assisted thoracoscopic surgery (NIVATS). Participants will be evaluated during the surgery and again at 2 hours and 24 hours post-operation to monitor any changes in diaphragmatic function. The study focuses on patients undergoing procedures such as wedge resections, pneumothorax repair, and pleural biopsies. Data will be meticulously recorded by physicians in an electronic case report form (CRF).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing non-intubated video-assisted thoracoscopic surgery.
Not a fit: Patients with pre-existing diaphragmatic dysfunction or those not affiliated with the French social security system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of diaphragmatic dysfunction following thoracic surgeries.
How similar studies have performed: While there may be studies on diaphragmatic function post-surgery, this specific approach focusing on non-intubated techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 years or older * Patient who has read and signed the informed consent form for participation in the study * Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation Exclusion Criteria: * Known or detected diaphragmatic dysfunction before the intervention * Patient not affiliated with the French social security system * Patient under legal protection, guardianship, or curatorship * Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies) * Patient in an exclusion period from a previous clinical study * Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol
Where this trial is running
Quincy-sous-Sénart
- Hôpital Privé Claude Galien — Quincy-sous-Sénart, France (Recruiting)
Study contacts
- Study coordinator: Nabil ZANOUN, MD
- Email: nabil.zanoun@yahoo.fr
- Phone: 01 69 39 15 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.