- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03630887
Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
June 9, 2020 updated by: Ángel Becerra, Dr. Negrin University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
297
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Las Palmas
-
Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
- Ángel Becerra
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
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.
|
|
EXPERIMENTAL: Prewarming during 15 minutes
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.
|
Forced-air warming will be applied in the preanesthetic room during different time periods.
|
EXPERIMENTAL: Prewarming during 30 minutes
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.
|
Forced-air warming will be applied in the preanesthetic room during different time periods.
|
EXPERIMENTAL: Prewarming during 45 minutes
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.
|
Forced-air warming will be applied in the preanesthetic room during different time periods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers)
Time Frame: Throughout surgery, an average of 60 minutes.
|
To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection.
|
Throughout surgery, an average of 60 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay in Post-Anesthetic Care Unit (in minutes)
Time Frame: Stay in Post-Anesthetic Care Unit, an average of 6 hours.
|
To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection.
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Stay in Post-Anesthetic Care Unit, an average of 6 hours.
|
Postoperative shivering (using a dichotomous scale: yes or no)
Time Frame: Immediate postoperative period, an average of 1 hour.
|
To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection.
|
Immediate postoperative period, an average of 1 hour.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ángel Becerra, MD, Dr. Negrin University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 14, 2018
Primary Completion (ACTUAL)
October 31, 2018
Study Completion (ACTUAL)
October 31, 2018
Study Registration Dates
First Submitted
August 8, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (ACTUAL)
August 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTU-2018-153-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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