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Effect of Perioperative Lung Protective Strategies on the Occurrence of Postoperative Pulmonary Complications in Patients Undergoing Lumbar Spinal Surgery in the Prone Position

NCT02373475 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2016-06-15

No results posted yet for this study

Summary

Postoperative pulmonary complications are main cause of overall perioperative morbidity and mortality in the patients following general anesthesia. A protective ventilation strategy refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective ventilation has been considered the optimal practice in patients suffering from the acute respiratory distress syndrome (ARDS). However, few human studies have assessed how to ventilate healthy lungs in patients undergoing general anesthesia, especially in prone position. Prior studies reported that in the patients undergoing major abdominal surgery in supine position, intraoperative lung protective ventilator settings had the potential to protect against pulmonary complications. Therefore, the investigators planned this study to better specify the effect of intraoperative protective ventilation in surgical patients in the prone position.

Conditions

  • Pulmonary Complications

Interventions

OTHER

Conventional ventilation

Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia

OTHER

Protective lung ventilation

Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-01-31
Completion
2016-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02373475 on ClinicalTrials.gov