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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diaphragmatic Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diaphragmatic Dysfunction evaluation

Group Type EXPERIMENTAL

NIVATS

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No