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 volunteersQualifiers
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
Single group
Treatments tested in this trial
NIVATS
Procedure/SurgeryNon-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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Pain evaluation
Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).
Pain evaluation
Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.