- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02416557
Effect of PEEP on Intraoperative Hypothermia
Effect of Positive End Expiratory Pressure on Intraoperative Body Temperature in Patients Undergoing Spine Surgery; a Prospective Randomized Study
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hee Pyung Park, MD PhD
- Phone Number: 82-2-2072-2466
- Email: hppark@snu.ac.kr
Study Contact Backup
- Name: Hyungseok Seo, MD
- Phone Number: 82-2072-2469
- Email: seohyungseok@gmail.com
Study Locations
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Seoul, Korea, Republic of, 110-799
- Seoul National University of Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group P
Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively
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application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation
Other Names:
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No Intervention: Group C
Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body temperature as assessed by esophageal temperature probe
Time Frame: 180 minutes after the completion of anesthesia induction
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Body temperature is assessed by esophageal temperature probe.
The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome
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180 minutes after the completion of anesthesia induction
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thermoregulatory vasoconstriction threshold
Time Frame: until 180 minutes after the completion of anesthesia induction
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The time of the difference in skin temperature between forearm and fingertip becoming zero.
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until 180 minutes after the completion of anesthesia induction
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Intraoperative hypothermia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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