Effect of PEEP on Intraoperative Hypothermia

Not Applicable

• Conditions: Spinal Diseases
• Interventions: Procedure: PEEP

• Registration Number: NCT02416557
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Intraoperative hypothermia is associated with many clinical adverse outcomes. Many techniques were applied to prevent intraoperative hypothermia, and positive end-expiratory pressure (PEEP) has been known to blunt intraoperative hypothermia by increasing thermoregulatory vasoconstriction threshold. The investigators assessed the effect of PEEP on the prevention of intraoperative hypothermia during spine surgery in prone position.

Detailed Description

It is well known that intraoperative hypothermia is associated with postoperative adverse clinical outcomes in various study populations. Intraoperative hypothermia has various adverse effects including impaired drug clearance, cold diuresis and hypovolemia, immunosuppression with increased infection risk, electrolyte disorders, coagulopathy with impaired platelet function, negative nitrogen balance, shivering, insulin resistance, and myocardial events. Numerous methods have been introduced to prevent intraoperative hypothermia, such as warming of infusion fluid, forced-air warming, heat-pads, heated water mattress, and heated humidifiers. However, in patients undergoing lumbar spine surgery in the prone position, these methods to prevent intraoperative hypothermia may partially effective because these methods, in clinical practice, have a significant limitation in their application.

Positive end-expiratory pressure (PEEP) reduces the venous return by increasing intrathoracic pressure. This causes carotid unloading, which leads to a secondary peripheral vasoconstriction by increasing thermoregulatory vasoconstriction threshold and blunts intraoperative hypothermia. Previous studies demonstrated that intraoperative PEEP significantly attenuated the extent of intraoperative hypothermia in patients undergoing tympanoplasty. However, the beneficial effect of PEEP on thermoregulation is not investigated in patients with the prone position for spinal surgery.

The investigators hypothesized that PEEP can reduce the extent of intraoperative hypothermia via thermoregulatory modulation. In this study, the investigators investigated the effect of PEEP on intraoperative core body temperature and the incidence of intraoperative hypothermia in patients undergoing spinal surgery

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-09
• Last Update Submitted: 2015-04-09
• Study First Posted: 2015-04-15
• Last Update Posted: 2015-04-15
• Study Start: 2015-05
• Primary Completion: 2017-05
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients who were scheduled for elective spine surgery requiring more than 3 hours

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Exclusion Criteria

• Patients who do not agree to the study
• Patients with or American Society of Anesthesiologists (ASA) physical status class 3 or more
• Patients with thyroid disease, peripheral vascular diseases, uncontrolled diabetes or hypertension
• Patients with morbid obesity (BMI >35 kg/m2)
• Patients with clinically severe pulmonary disease
• Patients undergoing simultaneous anterior and posterior lumbar fusion surgery were also excluded.
• Patients with taking non-steroidal anti-inflammatory drug within two weeks
• Patients with preoperative fever or hypothermia
• Patients with intraoperative intentional hypothermia for neuroprotection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	PEEP	Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively

Primary Outcome Measures

Name	Time	Method
Body temperature as assessed by esophageal temperature probe	180 minutes after the completion of anesthesia induction	Body temperature is assessed by esophageal temperature probe. The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome

Secondary Outcome Measures

Name	Time	Method
Thermoregulatory vasoconstriction threshold	until 180 minutes after the completion of anesthesia induction	The time of the difference in skin temperature between forearm and fingertip becoming zero.

Trial Locations

Locations (1)

Seoul National University of Hospital; 🇰🇷 Seoul, Korea, Republic of