Effect of PEEP on Intraoperative Hypothermia

Spinal Diseases Clinical Trial

Official title:

Effect of Positive End Expiratory Pressure on Intraoperative Body Temperature in Patients Undergoing Spine Surgery; a Prospective Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02416557
• Other study ID #: Intraoperative hypothermia
• Status: Not yet recruiting
• Phase: N/A
• First received: April 6, 2015
• Last updated: April 9, 2015
• Start date: May 2015
• Est. completion date: July 2017

Study information

• Verified date: April 2015
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Spinal Diseases

Intervention

Procedure:
• PEEP
application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body temperature as assessed by esophageal temperature probe	Body temperature is assessed by esophageal temperature probe. The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome	180 minutes after the completion of anesthesia induction	No
Secondary	Thermoregulatory vasoconstriction threshold	The time of the difference in skin temperature between forearm and fingertip becoming zero.	until 180 minutes after the completion of anesthesia induction	No