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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
120
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.
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France
RECRUITINGDiaphragmatic 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
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
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
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
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
postoperative complications evaluation
The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration. Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.
Karim GUESSOUS, MD
CONTACT
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Time frame: Hour 2
postoperative complications evaluation
The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration. Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.
Time frame: Hour 24