A trial of intraoperative low-tidal-volume ventilation in abdominal surgery

N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

Abstract

Background: Lung-protective ventilation with the use of low tidal volumes and positive end-expiratory pressure is considered best practice in the care of many critically ill patients. However, its role in anesthetized patients undergoing major surgery is not known.

Methods: In this multicenter, double-blind, parallel-group trial, we randomly assigned 400 adults at intermediate to high risk of pulmonary complications after major abdominal surgery to either nonprotective mechanical ventilation or a strategy of lung-protective ventilation. The primary outcome was a composite of major pulmonary and extrapulmonary complications occurring within the first 7 days after surgery.

Results: The two intervention groups had similar characteristics at baseline. In the intention-to-treat analysis, the primary outcome occurred in 21 of 200 patients (10.5%) assigned to lung-protective ventilation, as compared with 55 of 200 (27.5%) assigned to nonprotective ventilation (relative risk, 0.40; 95% confidence interval [CI], 0.24 to 0.68; P=0.001). Over the 7-day postoperative period, 10 patients (5.0%) assigned to lung-protective ventilation required noninvasive ventilation or intubation for acute respiratory failure, as compared with 34 (17.0%) assigned to nonprotective ventilation (relative risk, 0.29; 95% CI, 0.14 to 0.61; P=0.001). The length of the hospital stay was shorter among patients receiving lung-protective ventilation than among those receiving nonprotective ventilation (mean difference, -2.45 days; 95% CI, -4.17 to -0.72; P=0.006).

Conclusions: As compared with a practice of nonprotective mechanical ventilation, the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization. (IMPROVE ClinicalTrials.gov number, NCT01282996.).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Abdomen / surgery*
  • Digestive System Surgical Procedures
  • Double-Blind Method
  • Female
  • Humans
  • Intention to Treat Analysis
  • Male
  • Middle Aged
  • Operative Time
  • Positive-Pressure Respiration / methods*
  • Postoperative Complications / prevention & control*
  • Postoperative Complications / therapy
  • Respiratory Insufficiency / etiology
  • Respiratory Insufficiency / prevention & control*
  • Respiratory Insufficiency / therapy
  • Tidal Volume*

Associated data

  • ClinicalTrials.gov/NCT01282996