Diaphragmatic Dysfunction
Conditions
Brief summary
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.
Detailed 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
Interventions
PROCEDURENIVATS
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.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragmatic excursion | Hour 24 | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation | Hour 2 | Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced). |
| Diaphragmatic thickening evaluation | Hour 2 | Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness |
| postoperative complications evaluation | Hour 2 | 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. |
Countries
France
Contacts
Primary ContactNabil ZANOUN, MD
Backup ContactKarim GUESSOUS, MD
Outcome results
None listed