Effect of PEEP on Intraoperative Hypothermia
Primary Purpose
Spinal Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEEP
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Diseases
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
Sites / Locations
- Seoul National University of Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group P
Group C
Arm Description
Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively
Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Thermoregulatory vasoconstriction threshold
The time of the difference in skin temperature between forearm and fingertip becoming zero.
Full Information
NCT ID
NCT02416557
First Posted
April 6, 2015
Last Updated
April 9, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02416557
Brief Title
Effect of PEEP on Intraoperative Hypothermia
Official Title
Effect of Positive End Expiratory Pressure on Intraoperative Body Temperature in Patients Undergoing Spine Surgery; a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group P
Arm Type
Experimental
Arm Description
Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively
Intervention Type
Procedure
Intervention Name(s)
PEEP
Other Intervention Name(s)
positive end expiratory pressure
Intervention Description
application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation
Primary Outcome Measure Information:
Title
Body temperature as assessed by esophageal temperature probe
Description
Body temperature is assessed by esophageal temperature probe. The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome
Time Frame
180 minutes after the completion of anesthesia induction
Secondary Outcome Measure Information:
Title
Thermoregulatory vasoconstriction threshold
Description
The time of the difference in skin temperature between forearm and fingertip becoming zero.
Time Frame
until 180 minutes after the completion of anesthesia induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Pyung Park, MD PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyungseok Seo, MD
Phone
82-2072-2469
Email
seohyungseok@gmail.com
Facility Information:
Facility Name
Seoul National University of Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25107714
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.
Results Reference
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PubMed Identifier
11004013
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. doi: 10.1152/ajpregu.2000.279.4.R1430.
Results Reference
background
PubMed Identifier
25097736
Citation
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.
Results Reference
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Effect of PEEP on Intraoperative Hypothermia
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