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

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Diaphragmatic Dysfunction

Treatments

Procedure: NIVATS

Study type

Interventional

Funder types

Other

Identifiers

NCT06486168
2024-A00912-45

Details and patient eligibility

About

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.

Full 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

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Diaphragmatic Dysfunction evaluation
Experimental group
Treatment:
Procedure: NIVATS

Trial contacts and locations

1

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Central trial contact

Nabil ZANOUN, MD; Karim GUESSOUS, MD

Data sourced from clinicaltrials.gov

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