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Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

Primary Purpose

Hypothermia; Anesthesia, Perioperative/Postoperative Complications, Complication of Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Sponsored by
Dr. Negrin University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia; Anesthesia focused on measuring Prewarming, Tympanic temperature, Transurethral Resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective Transurethral resection under general or spinal anesthesia.
  • Patients older tan 18 years old.
  • American Society of Anesthesiologists physical status classification I - III.
  • Absence of cognitive impairment.
  • Written informed consent before enrollment.

Exclusion Criteria:

  • American Society of Anesthesiologists physical status classification I - III.
  • Pregnancy.
  • Active infection.
  • Intake of antipyretics within 24 hours before surgery.
  • Neuropathy.
  • Thyroid disorders.
  • Peripheral vascular disease.
  • Skin lesions.
  • History of hypersensitivity to skin contact devices.

Sites / Locations

  • Ángel Becerra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Prewarming during 15 minutes

Prewarming during 30 minutes

Prewarming during 45 minutes

Arm Description

Non-active prewarming. Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.

Active Prewarming will be performed during 15 minutes, using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.

Active Prewarming will be performed during 30 minutes, using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.

Active Prewarming will be performed during 45 minutes, using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.

Outcomes

Primary Outcome Measures

Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers)
To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection.

Secondary Outcome Measures

Length of stay in Post-Anesthetic Care Unit (in minutes)
To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection.
Postoperative shivering (using a dichotomous scale: yes or no)
To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection.

Full Information

First Posted
August 8, 2018
Last Updated
June 9, 2020
Sponsor
Dr. Negrin University Hospital
Collaborators
University of Las Palmas de Gran Canaria
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1. Study Identification

Unique Protocol Identification Number
NCT03630887
Brief Title
Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
Official Title
Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Negrin University Hospital
Collaborators
University of Las Palmas de Gran Canaria

4. Oversight

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

5. Study Description

Brief Summary
Hypothermia is a frequent perioperative complication. When the negative effects of anesthesia on temperature are aggravated by other factors, such as glycine infusion in transurethral resection, temperature can decrease even more. Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate the optimal time period of preoperative forced-air warming to reduce the incidence of hypothermia at the end of surgery in patients submitted to transurethral resection. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 144 patients are going to be included in this study (36 patients in each group). Measurement of temperature will be performed using a tympanic thermometer. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.
Detailed Description
Maintaining patient's temperature above 36 grades Celsius throughout the perioperative period is challenging. Thus, it is essential to monitor temperature in order to be able to take measures to avoid the appearance of hypothermia. Once the temperature has decreased, its treatment is difficult since the application of heat to the body surface takes a long time to reach the core thermal compartment. Intraoperative warming alone cannot avoid postoperative hypothermia. The application of forced-air warming system during the preoperative period has been shown to be the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, it would not be efficient to provide a long-time prewarming in short-term surgical procedures. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection, the conductance of this clinical trial is justified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia, Perioperative/Postoperative Complications, Complication of Anesthesia, Temperature Change, Body, Anaesthesia Complication, Transurethral Resection Syndrome
Keywords
Prewarming, Tympanic temperature, Transurethral Resection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. Sample size was authorized by IRB to be changed from 144 to 244 (61 patients per group) due to possible missing data.
Masking
Care ProviderInvestigator
Masking Description
Randomization will be carried out by a collaborator investigator using a computer program (Excel 2016) when a new patient is included into the clinical trial. This collaborator investigator will call by phone the nurse in charge of receiving the patient in the preanesthetic room, telling this nurse how long prewarming has to be given to the patient: 0 minutes (no prewarming), 15 minutes, 30 minutes or 45 minutes, according to the group given by the computer program. This collaborator investigator will not provide clinical care to the patient. Thus, principal investigator will not be able to know how long prewarming will be given by the nurse to the patient (chosen by the computer program and organized by a collaborator investigator)
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Non-active prewarming. Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.
Arm Title
Prewarming during 15 minutes
Arm Type
Experimental
Arm Description
Active Prewarming will be performed during 15 minutes, using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.
Arm Title
Prewarming during 30 minutes
Arm Type
Experimental
Arm Description
Active Prewarming will be performed during 30 minutes, using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.
Arm Title
Prewarming during 45 minutes
Arm Type
Experimental
Arm Description
Active Prewarming will be performed during 45 minutes, using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be actively warmed during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.
Intervention Type
Device
Intervention Name(s)
WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Intervention Description
Forced-air warming will be applied in the preanesthetic room during different time periods.
Primary Outcome Measure Information:
Title
Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers)
Description
To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection.
Time Frame
Throughout surgery, an average of 60 minutes.
Secondary Outcome Measure Information:
Title
Length of stay in Post-Anesthetic Care Unit (in minutes)
Description
To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection.
Time Frame
Stay in Post-Anesthetic Care Unit, an average of 6 hours.
Title
Postoperative shivering (using a dichotomous scale: yes or no)
Description
To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection.
Time Frame
Immediate postoperative period, an average of 1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective Transurethral resection under general or spinal anesthesia. Patients older tan 18 years old. American Society of Anesthesiologists physical status classification I - III. Absence of cognitive impairment. Written informed consent before enrollment. Exclusion Criteria: American Society of Anesthesiologists physical status classification I - III. Pregnancy. Active infection. Intake of antipyretics within 24 hours before surgery. Neuropathy. Thyroid disorders. Peripheral vascular disease. Skin lesions. History of hypersensitivity to skin contact devices.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ángel Becerra, MD
Organizational Affiliation
Dr. Negrin University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ángel Becerra
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.
Citations:
PubMed Identifier
34675311
Citation
Becerra A, Valencia L, Saavedra P, Rodriguez-Perez A, Villar J. Effect of prewarming on body temperature in short-term bladder or prostatic transurethral resection under general anesthesia: A randomized, double-blind, controlled trial. Sci Rep. 2021 Oct 21;11(1):20762. doi: 10.1038/s41598-021-00350-2.
Results Reference
derived

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Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

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