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

Pulmonary Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373475
• Other study ID #: 4-2014-0955
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2015
• Last updated: June 13, 2016
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

• Emergency operation

• Patient refusal

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pulmonary Complications

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	forced vital capacity (FVC)	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.	3 days after the spine surgery	No
Primary	forced expiratory volume in 1 second (FEV1)	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.	3 days after the spine surgery	No