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Clinical Trials/NCT02373475
NCT02373475
Completed
Phase 4

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

Yonsei University1 site in 1 country78 target enrollmentFebruary 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pulmonary Complications
Sponsor
Yonsei University
Enrollment
78
Locations
1
Primary Endpoint
forced vital capacity (FVC)
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • the patient undergoing elective lumbar spine surgery of two hours or more in the prone position
  • the age: 19 yrs and older
  • the patients had a preoperative risk index for pulmonary complications of more than 2.

Exclusion Criteria

  • Patients with altered mental status or increased intracranial pressure
  • Body mass index more than 35 kg/m2
  • Patients with persistent hemodynamic instability or intractable shock
  • Severe cardiac disease defined as New York Heart Association class III or IV or acute coronary syndrome or persistent ventricular tachyarrhythmias
  • Recent history of invasive ventilation (within two weeks)
  • Recent history of pneumonia, ALI/ARDS or sepsis (within two weeks)
  • History of pulmonary resection, emphysema or chronic obstructive pulmonary disease (COPD)
  • Repeated systemic corticosteroid therapy for acute exacerbations of COPD or asthma
  • Recent immunosuppressive medication defined as need of chemotherapy or radiation therapy (within two months)
  • History of neuromuscular disease

Outcomes

Primary Outcomes

forced vital capacity (FVC)

Time Frame: 3 days after the spine surgery

The changes in the pulmonary functional tests \[forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)\].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.

forced expiratory volume in 1 second (FEV1)

Time Frame: 3 days after the spine surgery

The changes in the pulmonary functional tests \[forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1)\].Pulmonary functional tests were performed at the bedside by using a spirometer while the patients in a seated, comfortable position.

Study Sites (1)

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