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

NCT02373475 | Completed Phase 4

• 1 other identifier: 4-2014-0955
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Complications

Keywords

spine surgery; prone position; intraoperative lung protective strategies; postoperative pulmonary complications

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Conventional ventilation

EXPERIMENTAL

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

Protective lung ventilation

ACTIVE COMPARATOR

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

Interventions

Conventional ventilation OTHER

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

Conventional ventilation

Protective lung ventilation OTHER

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

Protective lung ventilation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine

Seoul, Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 27, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

KR (1)