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Effect of PEEP on Intraoperative Hypothermia

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Seoul National University

Status

Unknown

Conditions

Spinal Diseases

Treatments

Procedure: PEEP

Study type

Interventional

Funder types

Other

Identifiers

NCT02416557
Intraoperative hypothermia

Details and patient eligibility

About

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.

Full 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

Enrollment

42 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

Group P
Experimental group
Description:
Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively
Treatment:
Procedure: PEEP
Group C
No Intervention group
Description:
Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively

Trial contacts and locations

1

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Central trial contact

Hee Pyung Park, MD PhD; Hyungseok Seo, MD

Data sourced from clinicaltrials.gov

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