Hypothermia; AnesthesiaNCT03630887
Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
A study testing WarmTouch Model 5900, Covidien Ltd, Mansfield, USA in people with Hypothermia; Anesthesia and Perioperative/Postoperative Complications, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia; Anesthesia, Perioperative/Postoperative Complications, Complication of Anesthesia
- What is being tested?
- WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteSpain
- Study dates
- 14 Aug 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- American Society of Anesthesiologists physical status classification I - III.
- Pregnancy.
- Active infection.
- Intake of antipyretics within 24 hours before surgery.
- Neuropathy.
- Thyroid disorders.
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- Peripheral vascular disease.
- Skin lesions.
- History of hypersensitivity to skin contact devices.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypothermia; Anesthesia, Perioperative/Postoperative Complications, Complication of Anesthesia, Temperature Change, Body, Anaesthesia Complication, Transurethral Resection Syndrome
- Being tested
- WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
- Keywords
- Prewarming, Tympanic temperature, Transurethral Resection
- Medical subject headings
- Hypothermia, Postoperative Complications, Body Temperature Changes, Transurethral resection syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarmTouch Model 5900, Covidien Ltd, Mansfield, USADevice
Forced-air warming will be applied in the preanesthetic room during different time periods.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Prewarming during 15 minutes | Experimental | 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. Receives: Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA |
| Prewarming during 30 minutes | Experimental | 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. Receives: Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA |
| Prewarming during 45 minutes | Experimental | 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. Receives: Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout surgery, an average of 60 minutes.
Secondary outcomes (2)
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.
Measured: Stay in Post-Anesthetic Care Unit, an average of 6 hours.
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.
Measured: Immediate postoperative period, an average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start14 Aug 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Collaborators
- University of Las Palmas de Gran Canaria
- Responsible party
- Principal investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Becerra, MD, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630887
- Sponsor's protocol ID
- RTU-2018-153-1
- Status last verified
- Jun 2020
- First submitted
- 8 Aug 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.
Publications
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.
PubMed 34675311
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
- ClinicalTrials.gov ID
- NCT03630887
- Acronym / sponsor ID
- RTU-2018-153-1
- Conditions
- Hypothermia; Anesthesia, Perioperative/Postoperative Complications, Complication of Anesthesia, Temperature Change, Body, Anaesthesia Complication, Transurethral Resection Syndrome
- Keywords
- Prewarming, Tympanic temperature, Transurethral Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Collaborators
- University of Las Palmas de Gran Canaria
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Prewarming during 15 minutes | Experimental | Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USAActive 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. |
| Prewarming during 30 minutes | Experimental | Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USAActive 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. |
| Prewarming during 45 minutes | Experimental | Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USAActive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists physical status classification I - III.
- Pregnancy.
- Active infection.
- Intake of antipyretics within 24 hours before surgery.
- Neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarmTouch Model 5900, Covidien Ltd, Mansfield, USAForced-air warming will be applied in the preanesthetic room during different time periods. | Device | Prewarming during 15 minutes, Prewarming during 30 minutes, Prewarming during 45 minutes |
Primary outcome
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.
2 secondary outcomes
Length of stay in Post-Anesthetic Care Unit (in minutes)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 34675311Becerra 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.
- Individual participant dataSharing planned: Undecided. Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ángel Becerra, MD principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WarmTouch Model 5900, Covidien Ltd, Mansfield, USA in people with Hypothermia; Anesthesia and Perioperative/Postoperative Complications, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers) (time frame: Throughout surgery, an average of 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.