Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery
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: NIVATS.
- Who it may be relevant to
- Registry conditions: Diaphragmatic Dysfunction. 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
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.
Overview
The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS). Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.
Detailed description
This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.
Except for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF
Interventions
- Procedure NIVATS
Non-Intubated Video-Assisted Thoracic Surgery (NIVATS) is the least invasive approach available. It is part of an optimal Enhanced Recovery After Surgery (ERAS) pathway and allows for expanding surgical indications in patients with poor cardio-pulmonary function.
Primary outcome measures
- Diaphragmatic excursion [Time frame: Hour 24]
Secondary outcome measures (6)
- Pain evaluation [Time frame: Hour 2]
- Pain evaluation [Time frame: Hour 24]
- Diaphragmatic thickening evaluation [Time frame: Hour 2]
- Diaphragmatic thickening evaluation [Time frame: Hour 24]
- postoperative complications evaluation [Time frame: Hour 2]
- postoperative complications evaluation [Time frame: Hour 24]
Eligibility 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
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
- Prevention
Study locations
France · 1 center
- Hôpital Privé Claude Galien — Quincy-sous-Sénart
Publications
- Guessous K, Elmaleh Y, Kattou F, Coblence M, Dore P, Zanoun N. Incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery: a prospective, single-centre observational study protocol. BMJ Open. 2025 Dec 31;15(12):e107479. doi: 10.1136/bmjopen-2025-107479. PMID 41475807
Identifiers
NCT: NCT06486168 · 2024-A00912-45