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

ConditionLung Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bipulmonary Reventilation using the accessory circuit

    Procedure/Surgery

    Bipulmonary Reventilation using the accessory circuit

  • Bipulmonary Reventilation under controlled ventilation

    Procedure/Surgery

    Bipulmonary Reventilation under controlled ventilation

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Bipulmonary reventilation arm using the accessory circuitOther 1 intervention
Group B: Bipulmonary reventilation arm under controlled ventilationExperimental treatment 1 intervention

Trial outcomes

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)).

Time frame
7 postoperative days

Secondary outcomes

1

Number of postoperative pulmonary complications

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.

Time frame
7 postoperative days
2

Number of Death

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.

Time frame
30 postopeatives days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: