Effect of Bilateral vs. Unilateral Alveolar Recruitment on Gas Exchange in Lung Resection

NCT ID: NCT07044661

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2027-06-10

Brief Summary

"One-lung ventilation (OLV) is an essential technique during thoracic surgery but preventing atelectasis during OLV remains a key challenge in thoracic anesthesia.

Several previous randomized controlled trials have demonstrated that alveolar recruitment maneuvers (ARMs) can significantly reduce driving pressure, peak airway pressure, plateau pressure, and anatomical dead space. However, the optimal method for implementing ARMs has not yet been standardized, as the timing and target of ARM application vary among studies. Some protocols involve applying ARMs to both lungs immediately prior to the initiation of OLV (bilateral ARM), while others apply ARMs solely to the non-operative lung after OLV has begun (unilateral ARM). Bilateral ARM may provide prolonged improvement in gas exchange but carry the risk of insufficient collapse of the operative lung. Conversely, unilateral ARM may facilitate better collapse of the operative lung compared to bilateral ARMs, though potentially at the expense of gas exchange. To date, no study has directly compared these two approaches. This study aims to compare and evaluate the effects of bilateral versus unilateral ARM performed immediately prior to thoracic incision on intraoperative gas exchange and the incidence of intraoperative and postoperative complications."

Conditions

Lung Cancer Requiring Surgical Resection Under One-lung Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Uni-ARM group

Unilateral ARM is performed immediately after lateral decubitus positioning of the patient, followed by lung-protective mechanical ventilation with individualized PEEP.

Group Type: ACTIVE_COMPARATOR

Unilateral ARM

Intervention Type: PROCEDURE

ARM is performed to the dependent lung only. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles.

Bi-ARM group

Bilateral ARM is performed immediately after lateral decubitus positioning of the patient, followed by lung-protective mechanical ventilation with individualized PEEP.

Group Type: EXPERIMENTAL

Bilateral ARM

Intervention Type: PROCEDURE

ARM is performed to both lungs. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles.

Interventions

Unilateral ARM

ARM is performed to the dependent lung only. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles.

Intervention Type: PROCEDURE

Bilateral ARM

ARM is performed to both lungs. During ARM, mechanical ventilation is set to a pressure-controlled ventilation mode with a driving pressure of 20 cmH₂O and an inspiratory-to-expiratory ratio of 1:1. The positive end-expiratory pressure (PEEP) is increased by 5 cmH₂O every five respiratory cycles, reaching a final PEEP of 20 cmH₂O and a peak airway pressure of 40 cmH₂O, which is then maintained for ten respiratory cycles.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• -Adult patients aged 20 to 80 years scheduled for thoracoscopic lung resection.
• American Society of Anesthesiologists (ASA) physical status classification of I to III.

Exclusion Criteria

• Anticipated duration of one-lung ventilation (OLV) less than 1 hour.
• Diagnosis of heart failure.
• History of pneumothorax or radiologic evidence of pulmonary blebs or bullae prior to surgery.
• Patients receiving supplemental oxygen therapy or mechanical ventilation prior to surgery.

Dropout Criteria

• Actual duration of OLV less than 1 hour.
• Surgery is canceled or converted to an open thoracotomy or another surgical approach.
• Inability to maintain peripheral oxygen saturation ≥90% despite adjustments in inspired oxygen fraction.
• Inability to maintain ventilator settings due to extensive pulmonary adhesions.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2025-0522

Identifier Type: -

Identifier Source: org_study_id