Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung R… (NCT05525312) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery.
France120 participantsStarted 2024-03-20
Plain-language summary
During thoracic surgery, one-lung ventilation (OLV) is associated with hypoxemia, lung injury, and perioperative respiratory complications. The level of positive-end expiratory pressure (PEEP) to apply during OLV remains controversial. The open-lung approach consists in setting a level of PEEP corresponding to the best lung compliance, using an esophageal catheter to measure the transpulmonary pressure. This approach has been effective in laparoscopic surgeries or acute respiratory distress syndrome, but has never been evaluated in thoracic surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* To be over 18 years old,
* To be able to attend all scheduled visits and to comply with all trial procedures,
* To be scheduled for a lung cancer resection surgery (performed by either video-assisted thoracoscopy or thoracotomy).
Exclusion Criteria:
* Non-carcinologic indication of lung resection (e.g. Lung volume reduction for bullous emphysema reduction, lung abscess),
* Bilateral pulmonary resection surgery or history of lung resection surgery,
* Lung resection under sternotomy
* Non intubated video-assisted thoracoscopy
* Robotic thoracic surgery
* Contraindication to esophageal catheter (history of esophageal varices, hepatic cirrhosis child ≥ b, esophageal or gastric surgery, thoracic radiotherapy, latex allergy),
* ASA (American Society of Anesthesiologists) score ≥ 4,
* Chronic obstructive pulmonary disease GOLD III or IV (Forced Expiratory Volume, FEV\<50%),
* Uncontrolled asthma (FEV \<50%),
* Intracardiac shunt,
* Hemoglobinopathy making the SpO2 values invalid,
* Heart failure NYHA III or IV,
* Documented pulmonary hypertension (Mean Pulmonary Arterial Pressure at rest, mPAP\>20 mmHg),
* To be under legal protection,
* Unable to read or write,
* Lack of informed consent, or unable to give consent,
* Refusal to participate in the study,
* Pregnancy in progress or planned during the study period, pregnant or nursing women,
* Not being affiliated to a French social security system or being a beneficiary of such a system.
What they're measuring
1
The incidence of intraoperative hypoxemia
Timeframe: During the Open-Lung Ventilation (OLV) period