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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Complications
• Intervention / Treatment: Other: Conventional ventilation; Other: Protective lung ventilation

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology and Pain Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 22, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Estimate): June 15, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: prone position; spine surgery; postoperative pulmonary complications; intraoperative lung protective strategies
• Other Study ID Numbers: 4-2014-0955