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Not Yet RecruitingNCT07044661

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
198 (estimated)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREUnilateral ARMARM 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.
PROCEDUREBilateral ARMARM 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.

Timeline

Start date
2025-07-10
Primary completion
2027-04-10
Completion
2027-06-10
First posted
2025-07-01
Last updated
2025-07-01

Locations

2 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT07044661. Inclusion in this directory is not an endorsement.