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NCT Number: NCT07247500

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'AMIENS, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Postmenopausal women (spontaneous, non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
  • Patient affiliated with a social security system.

Exclusion criteria

  • 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.

Treatment and study plan

Bipulmonary Reventilation using the accessory circuit

Procedure

Bipulmonary Reventilation using the accessory circuit

Bipulmonary Reventilation under controlled ventilation

Procedure

Bipulmonary Reventilation under controlled ventilation

Primary outcomes

  1. Postoperative pulmonary complications

    Time frame: 7 postoperative days

    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)).

Secondary outcomes

  1. Number of postoperative pulmonary complications

    Time frame: 7 postoperative days

    To compare the number of postoperative pulmonary complications between a group of patients who underwent a lung re-expansion technique using the accessory circuit and a group of patients who underwent a lung re-expansion technique using the machine circuit under controlled ventilation.

  2. Number of Death

    Time frame: 30 postopeatives days

    To compare the death level between a group of patients who underwent a lung re-expansion technique using the accessory circuit and a group of patients who underwent a lung re-expansion technique using the machine circuit under controlled ventilation.

Study contacts

Contact information is provided by the study sponsor or research team.

Nell Marty

CONTACT

[email protected]

0232888265

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: OLVREEXP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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