Effect of PEEP on Intraoperative Hypothermia

NCT ID: NCT02416557

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-07-31

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

Conditions

Spinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group P

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

Group Type: EXPERIMENTAL

PEEP

Intervention Type: PROCEDURE

application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation

Group C

Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PEEP

application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation

Intervention Type: PROCEDURE

Other Intervention Names

positive end expiratory pressure

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University of Hospital

Seoul, , South Korea

Countries

South Korea

Central Contacts

Hee Pyung Park, MD PhD

Role: CONTACT

hppark@snu.ac.kr

82-2-2072-2466

Hyungseok Seo, MD

Role: CONTACT

seohyungseok@gmail.com

82-2072-2469

References

Yamasaki H, Tanaka K, Funai Y, Suehiro K, Ikenaga K, Mori T, Osugi H, Nishikawa K. The impact of intraoperative hypothermia on early postoperative adverse events after radical esophagectomy for cancer: a retrospective cohort study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):943-7. doi: 10.1053/j.jvca.2014.02.013.

Reference Type: BACKGROUND

PMID: 25107714 (View on PubMed)

Nakajima Y, Mizobe T, Takamata A, Tanaka Y. Baroreflex modulation of peripheral vasoconstriction during progressive hypothermia in anesthetized humans. Am J Physiol Regul Integr Comp Physiol. 2000 Oct;279(4):R1430-6. doi: 10.1152/ajpregu.2000.279.4.R1430.

Reference Type: BACKGROUND

PMID: 11004013 (View on PubMed)

Jung KT, Kim SH, Lee HY, Jung JD, Yu BS, Lim KJ, So KY, Lee JY, An TH. Effect on thermoregulatory responses in patients undergoing a tympanoplasty in accordance to the anesthetic techniques during PEEP: a comparison between inhalation anesthesia with desflurane and TIVA. Korean J Anesthesiol. 2014 Jul;67(1):32-7. doi: 10.4097/kjae.2014.67.1.32. Epub 2014 Jul 29.

Reference Type: BACKGROUND

PMID: 25097736 (View on PubMed)

Other Identifiers

Intraoperative hypothermia

Identifier Type: -

Identifier Source: org_study_id