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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diaphragmatic Dysfunction
• Intervention / Treatment: Procedure: NIVATS

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabil ZANOUN, MD; Phone Number: 33 01 69 39 15 53; Email: nabil.zanoun@yahoo.fr
• Study Contact Backup: Name: Karim GUESSOUS, MD

Study Locations

• France
  • Quincy-sous-Sénart, France, 91480
    • Recruiting
    • Hôpital Privé Claude Galien
    • Contact: Nabil ZANOUN, MD; Phone Number: 33 01 69 39 15 53; Email: nabil.zanoun@yahoo.fr
    • Contact: Karim GUESSOUS, MD; Email: guess_02@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diaphragmatic Dysfunction evaluation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic excursion	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.	Hour 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation	Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).	Hour 2
Pain evaluation	Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).	Hour 24
Diaphragmatic thickening evaluation	Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness	Hour 2
Diaphragmatic thickening evaluation	Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness	Hour 24
postoperative complications evaluation	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.	Hour 2
postoperative complications evaluation	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.	Hour 24

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A00912-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only data strictly relevant to and directly used in the published article will be eligible for sharing. No data outside the scope of the published analysis will be provided.

IPD Sharing Access Criteria

Data may be made available upon explicit request from the journal and solely for the purpose of conducting a re-analysis of the published results. Requests must be submitted by email to the corresponding author. The statistical code used for the original analyses may also be shared if necessary. The study authors may be invited to participate in the re-analysis depending on the nature of the request.

Data will be provided as an anonymized Excel file, in compliance with applicable personal data protection regulations. No information allowing direct or indirect identification of study participants will be disclosed.

Shared data may be used only for the purpose defined in the initial request. No secondary use, data transfer agreement, or further data exploitation will be authorized.

• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No