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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Complications

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology and Pain Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 27, 2015
Registry last updated: Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed