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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • NIVATS

    Procedure/Surgery

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Diaphragmatic Dysfunction evaluationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Hour 24

Secondary outcomes

1

Pain evaluation

Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).

Time frame
Hour 2
2

Pain evaluation

Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).

Time frame
Hour 24
3

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

Time frame
Hour 2
4

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

Time frame
Hour 24

Other outcomes

Sponsors and contacts

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