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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diaphragmatic Dysfunction evaluation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIVATS | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Hour 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation | Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced). | Hour 2 |
| Pain evaluation | Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil ZANOUN, MD | Contact | 01 69 39 15 53 | 33 | nabil.zanoun@yahoo.fr |
| Karim GUESSOUS, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Claude Galien | Recruiting | Quincy-sous-Sénart | 91480 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41475807 | Derived | Guessous K, Elmaleh Y, Kattou F, Coblence M, Dore P, Zanoun N. Incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery: a prospective, single-centre observational study protocol. BMJ Open. 2025 Dec 31;15(12):e107479. doi: 10.1136/bmjopen-2025-107479. |
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Only data strictly relevant to and directly used in the published article will be eligible for sharing. No data outside the scope of the published analysis will be provided.
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Data may be made available upon explicit request from the journal and solely for the purpose of conducting a re-analysis of the published results. Requests must be submitted by email to the corresponding author. The statistical code used for the original analyses may also be shared if necessary. The study authors may be invited to participate in the re-analysis depending on the nature of the request.
Data will be provided as an anonymized Excel file, in compliance with applicable personal data protection regulations. No information allowing direct or indirect identification of study participants will be disclosed.
Shared data may be used only for the purpose defined in the initial request. No secondary use, data transfer agreement, or further data exploitation will be authorized.
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| 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 | 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 | 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. | 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. | Hour 24 |