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Does intraoperative low tidal volume, compared with conventional tidal volume, decrease postoperative pulmonary complications in patients undergoing major surgery?
In this randomized clinical trial of 1236 adults, the rate of pulmonary complications within the first 7 postoperative days was 38% among those randomized to a strategy of mechanical ventilation with low tidal volume compared with 39% among those randomized to a strategy with conventional tidal volume, a difference that was not statistically significant.
Among adults undergoing major surgery, an intraoperative mechanical ventilation strategy with low tidal volume did not significantly reduce postoperative pulmonary complications within the first 7 postoperative days.
In patients who undergo mechanical ventilation during surgery, the ideal tidal volume is unclear.
To determine whether low-tidal-volume ventilation compared with conventional ventilation during major surgery decreases postoperative pulmonary complications.
Design, Setting, and Participants
Single-center, assessor-blinded, randomized clinical trial of 1236 patients older than 40 years undergoing major noncardiothoracic, nonintracranial surgery under general anesthesia lasting more than 2 hours in a tertiary hospital in Melbourne, Australia, from February 2015 to February 2019. The last date of follow-up was February 17, 2019.
Patients were randomized to receive a tidal volume of 6 mL/kg predicted body weight (n = 614; low tidal volume group) or a tidal volume of 10 mL/kg predicted body weight (n = 592; conventional tidal volume group). All patients received positive end-expiratory pressure (PEEP) at 5 cm H2O.
Main Outcomes and Measures
The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, including pneumonia, bronchospasm, atelectasis, pulmonary congestion, respiratory failure, pleural effusion, pneumothorax, or unplanned requirement for postoperative invasive or noninvasive ventilation. Secondary outcomes were postoperative pulmonary complications including development of pulmonary embolism, acute respiratory distress syndrome, systemic inflammatory response syndrome, sepsis, acute kidney injury, wound infection (superficial and deep), rate of intraoperative need for vasopressor, incidence of unplanned intensive care unit admission, rate of need for rapid response team call, intensive care unit length of stay, hospital length of stay, and in-hospital mortality.
Among 1236 patients who were randomized, 1206 (98.9%) completed the trial (mean age, 63.5 years; 494 [40.9%] women; 681 [56.4%] undergoing abdominal surgery). The primary outcome occurred in 231 of 608 patients (38%) in the low tidal volume group compared with 232 of 590 patients (39%) in the conventional tidal volume group (difference, −1.3% [95% CI, −6.8% to 4.2%]; risk ratio, 0.97 [95% CI, 0.84-1.11]; P = .64). There were no significant differences in any of the secondary outcomes.
Conclusions and Relevance
Among adult patients undergoing major surgery, intraoperative ventilation with low tidal volume compared with conventional tidal volume, with PEEP applied equally between groups, did not significantly reduce pulmonary complications within the first 7 postoperative days.
ANZCTR Identifier: ACTRN12614000790640
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Corresponding Author: Dharshi Karalapillai, MD, Department of Intensive Care, Austin Hospital, Studley Road, Heidelberg, VIC 3084, Australia (email@example.com).
Accepted for Publication: June 30, 2020.
Author Contributions: Drs Karalapillai and Serpa Neto had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Karalapillai, Weinberg, Peyton, Story, Eastwood, Bellomo, Jones.
Acquisition, analysis, or interpretation of data: Karalapillai, Peyton, Ellard, Hu, Pearce, Tan, O’Donnell, Hamilton, Oughton, Galtieri, Wilson, Serpa Neto, Bellomo, Jones.
Drafting of the manuscript: Karalapillai, Weinberg, Peyton, Oughton, Serpa Neto, Eastwood, Bellomo, Jones.
Critical revision of the manuscript for important intellectual content: Karalapillai, Weinberg, Peyton, Ellard, Hu, Pearce, Tan, Story, O’Donnell, Hamilton, Galtieri, Wilson, Serpa Neto, Eastwood, Bellomo, Jones.
Statistical analysis: O’Donnell, Wilson, Serpa Neto, Jones.
Obtained funding: Karalapillai, Weinberg, Bellomo.
Administrative, technical, or material support: Karalapillai, Weinberg, Ellard, Hu, Tan, Oughton, Galtieri, Eastwood, Jones.
Supervision: Weinberg, Serpa Neto, Bellomo, Jones.
Conflict of Interest Disclosures: Dr Peyton reported receipt of personal fees from Maquet Critical Care. Dr Wilson reported receipt of personal fees from Fisher Paykel. No other disclosures were reported.
Funding/Support: This study was funded by Australian and New Zealand College of Anaesthetists grant ANZAC16/008.
Role of the Funder/Sponsor: The Australian and New Zealand College of Anaesthetists had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We acknowledge the contributions of Sarah Baulch, BN, Gayle Claxton, BN, Sofia Sidoropoulos, BN, and Saskia Harris, BN, research nurses in the Department of Anaesthesia, Austin Hospital, Melbourne. We also acknowledge the contributions of Raymond Robbins PhD, senior data analyst, Austin Health, Melbourne, and the team from the Data Analytics Research and Evaluation Center for assistance with data collection and retrieval. None received compensation for their role in the study.
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