Impact of Reventilation After One-Lung Ventilation in Thoracic Surgery (OLVREEXP)

NCT07247500 | Not Yet Recruiting

• 2 other identifiers: 2023/0303/HP2025-A01698-41
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lung cancer is a common disease, and more than 8,000 patients in France undergo lobectomy or pulmonary segmentectomy each year. This surgery remains associated with significant postoperative pulmonary complications, whose incidence ranges from 15% to 49% depending on the study (1). The main complication is pulmonary atelectasis, which provides a favorable setting for the development of postoperative pneumonia. In thoracic surgery, the operated lung is excluded, and one-lung ventilation is performed on the contralateral lung. During surgery, several strategies exist to prevent atelectasis during one-lung ventilation, known as protective ventilation strategies (2). At the end of the procedure, reventilation allows re-expansion of the previously excluded lung. However, pulmonary reventilation induces the release of pro-inflammatory cytokines and causes endothelial dysfunction, which may lead to pulmonary edema, thereby negating the benefits of intraoperative protective ventilation. Conversely, insufficient re-expansion may result in persistent postoperative atelectasis, whereas excessive re-expansion can cause volutrauma, alveolar trauma, and/or barotrauma to the operated lung (3). Several reventilation techniques are currently used, but to our knowledge, the impact of reventilation itself has never been specifically studied. The first, empirical technique, consists of reventilating both lungs using the accessory circuit and the adjustable pressure-limiting (APL) valve, manually bagging the patient over several respiratory cycles (4). The main drawback of this method is the lack of monitoring of insufflated volumes and pressures. The second, more recent technique, consists of reventilating the patient using the anesthesia machine circuit in controlled ventilation mode, which allows for precise monitoring of pressures and insufflated volumes (5). This approach provides real-time monitoring of lung re-expansion and could therefore be less harmful than the empirical method. Thus, the objective of this study is to compare postoperative pulmonary complications between patients who underwent lung re-expansion using the accessory circuit and those who underwent lung re-expansion using the anesthesia machine circuit in controlled ventilation mode.

Conditions

Lung Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pulmonary complications

  The evaluation of the primary endpoint will be performed by an anesthesiologist blinded to the lung re-expansion technique used. The composite endpoint will consist of the occurrence, within the first 7 postoperative days, of at least one pulmonary complications (postoperative pneumonia, pleural effusion, postoperative atelectasis, pneumothorax, bronchospasm, or acute respiratory distress syndrome (ARDS)).

  7 postoperative days

Secondary Outcomes (2)

• Number of postoperative pulmonary complications

  7 postoperative days

• Number of Death

  30 postopeatives days

Study Arms (2)

Bipulmonary reventilation arm using the accessory circuit

OTHER

As lobectomy and segmentectomy are procedures of differing complexity, stratification according to the type of surgery will ensure a balanced distribution between the study groups. However, despite their differences, both procedures have similar operative durations and require complete atelectasis of the operated lung. The main distinction lies in the amount of pulmonary parenchyma removed (approximately 10% for segmentectomy and 30% for lobectomy). This approach helps minimize bias related to variability in surgical procedures, as lobectomy is generally more invasive than segmentectomy. Consequently, each type of surgery will be represented comparably in both study groups. This stratification ensures that any differences observed between the groups can be attributed to the studied variable rather than to the type of surgical procedure.

Procedure: Bipulmonary Reventilation using the accessory circuit

Bipulmonary reventilation arm under controlled ventilation

EXPERIMENTAL

As lobectomy and segmentectomy are procedures of differing complexity, stratification according to the type of surgery will ensure a balanced distribution between the study groups. However, despite their differences, both procedures have similar operative durations and require complete atelectasis of the operated lung. The main distinction lies in the amount of pulmonary parenchyma removed (approximately 10% for segmentectomy and 30% for lobectomy). This approach helps minimize bias related to variability in surgical procedures, as lobectomy is generally more invasive than segmentectomy. Consequently, each type of surgery will be represented comparably in both study groups. This stratification ensures that any differences observed between the groups can be attributed to the studied variable rather than to the type of surgical procedure.

Procedure: Bipulmonary Reventilation under controlled ventilation

Interventions

Bipulmonary Reventilation using the accessory circuit PROCEDURE

Bipulmonary Reventilation using the accessory circuit

Bipulmonary reventilation arm using the accessory circuit

Bipulmonary Reventilation under controlled ventilation PROCEDURE

Bipulmonary Reventilation under controlled ventilation

Bipulmonary reventilation arm under controlled ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA score ≤ 3.
• Undergoing a scheduled video-assisted or robot-assisted lobectomy or segmentectomy.
• Patient has read and understood the information sheet and signed the informed consent form.
• For women of childbearing potential, effective contraception and confirmation of the absence of an ongoing pregnancy by a negative blood or urine pregnancy test are required.
• Patient affiliated with a social security system.

You may not qualify if:

• Patients with a BMI \> 40 kg/m².
• Patients with severe chronic respiratory failure (COPD grade 3, FEV₁/FVC \< 0.7 and FEV₁ \< 50% - according to the GOLD 2025 classification).
• Patients with severe chronic renal failure (GFR \< 30 mL/min).
• Patients at high risk of conversion to thoracotomy.
• Patients with a history of acute respiratory distress syndrome (ARDS) within 3 months prior to surgery.
• Patients with a known history of severe hepatic failure (Child-Pugh class B or C).
• Patients with a history of heart failure (NYHA class ≥ II).
• Patients with a history of pulmonary resection.
• Patients with uncontrolled asthma.
• Pregnant or breastfeeding women.
• Patients deprived of liberty by administrative or judicial decision, as well as those under legal protection, guardianship, or curatorship.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Central Study Contacts

Nell Marty

CONTACT

0232888265; nell.marty@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms in the study

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 8, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share