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10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

Primary Purpose

Urologic Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
prewarming and warmed fluid infusion
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urologic Diseases focused on measuring hypothermia

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients undergoing urologic surgery(transurethral resection of bladder, prostate)

Exclusion Criteria:

  • moderate to severe cardiopulmonary, renal impairment
  • thyroid disease
  • any infection sign
  • abnormal temperature prior to induction of general anesthesia (<36'C or >37.5'C)
  • refusal to participate in the study
  • unable to understand the study

Sites / Locations

  • Sanggye Paik Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

warming group

no warming group

Arm Description

Warming group patients are applied prewarming with bair-hugger (43'C)(warm touch, COVIDIEN, full body blanket) for 10 minutes in the preanesthetic unit prior to induction of anesthesia. During operation, prewarmed intravenous fluid which was stored in the warming cabinet for more than 8 hours is connected and infused. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.

No warming group patients are not applied prewarming devices. Intravenous fluid stored in room air is connected and infused during the operation. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.

Outcomes

Primary Outcome Measures

incidence of hypothermia at the end of the operation
after completion of the operation, number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.

Secondary Outcome Measures

change in temperature before and end of operation
change in core temperature will be calculated and compared
incidence of shivering
shivering will be evaluated using 4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body)
thermal comfort
thermal comfort will be evaluated using thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable)

Full Information

First Posted
July 16, 2021
Last Updated
November 23, 2022
Sponsor
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT04991272
Brief Title
10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature
Official Title
Effect of 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
August 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.
Detailed Description
During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation. Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected. Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases
Keywords
hypothermia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
warming group
Arm Type
Active Comparator
Arm Description
Warming group patients are applied prewarming with bair-hugger (43'C)(warm touch, COVIDIEN, full body blanket) for 10 minutes in the preanesthetic unit prior to induction of anesthesia. During operation, prewarmed intravenous fluid which was stored in the warming cabinet for more than 8 hours is connected and infused. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.
Arm Title
no warming group
Arm Type
No Intervention
Arm Description
No warming group patients are not applied prewarming devices. Intravenous fluid stored in room air is connected and infused during the operation. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.
Intervention Type
Other
Intervention Name(s)
prewarming and warmed fluid infusion
Intervention Description
prewarming with forced air warming system and warmed fluid infusion.
Primary Outcome Measure Information:
Title
incidence of hypothermia at the end of the operation
Description
after completion of the operation, number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.
Time Frame
approximately 1-2hours after induction (at the end of operation)
Secondary Outcome Measure Information:
Title
change in temperature before and end of operation
Description
change in core temperature will be calculated and compared
Time Frame
on arrival at the OR upto 1-2hours after induction (at the end of the operation)
Title
incidence of shivering
Description
shivering will be evaluated using 4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body)
Time Frame
upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
Title
thermal comfort
Description
thermal comfort will be evaluated using thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable)
Time Frame
upto 1hour after end of the operation (at discharge of postanesthesia care unit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients undergoing urologic surgery(transurethral resection of bladder, prostate) Exclusion Criteria: moderate to severe cardiopulmonary, renal impairment thyroid disease any infection sign abnormal temperature prior to induction of general anesthesia (<36'C or >37.5'C) refusal to participate in the study unable to understand the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jung Jun, MD. PhD
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

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