Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery

Not Applicable

Recruiting

• Conditions: Diaphragmatic Dysfunction
• Interventions: Procedure: NIVATS

• Registration Number: NCT06486168
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-09-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-09-02
• Study Completion: 2025-09-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diaphragmatic Dysfunction evaluation	NIVATS	-

Primary Outcome Measures

Name	Time	Method
Diaphragmatic excursion	Hour 24	The measurement of diaphragmatic excursion at H2 and H24 constitutes the primary evaluation criterion. Diaphragmatic excursion will be measured by ultrasound using a low-frequency probe (\< 5 MHz), either an abdominal or cardiac probe, positioned under the costal margin on the operated side and the contralateral side. To limit inter-operator variability, the patient's ultrasound evaluation will, as much as possible, be performed by the same operator. The presence of diaphragmatic dysfunction is defined by a diaphragmatic excursion of less than 1 cm.

Secondary Outcome Measures

Name	Time	Method
Pain evaluation	Hour 24	Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).
Diaphragmatic thickening evaluation	Hour 24	Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness
postoperative complications evaluation	Hour 24	The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.; Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France