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

NCT06486168 | Recruiting

• 1 other identifier: 2024-A00912-45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragmatic Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain evaluation

  Hour 2

• Pain evaluation

  Hour 24

• Diaphragmatic thickening evaluation

  Hour 2

• Diaphragmatic thickening evaluation

  Hour 24

• postoperative complications evaluation

  Hour 2

Study Arms (1)

Diaphragmatic Dysfunction evaluation

EXPERIMENTAL

Procedure: NIVATS

Interventions

NIVATS PROCEDURE

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.

Diaphragmatic Dysfunction evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

RECRUITING

Related Publications (1)

• 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 DERIVED

Central Study Contacts

Nabil ZANOUN, MD

CONTACT

01 69 39 15 53; nabil.zanoun@yahoo.fr

Karim GUESSOUS, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.

Locations

FR (1)