Hypothermia; AnesthesiaNCT03527329
Perioperative Hypothermia in Patients Submitted to Transurethral Resection
An observational study of Hypothermia; Anesthesia and Peroperative Complication, run by Hospital Universitario de Gran Canaria Doctor Negrín.
Trial summary
Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as myocardial ischemia or perioperative bleeding. When the negative effects of anesthesia on temperature are aggravated by other factors, such as glycine infusion in transurethral resection, temperature can decrease… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia; Anesthesia, Peroperative Complication
- What is being tested?
- WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to undergo elective transurethral resection between March 2014 and April 2018. Three-hundred patients are included in this study and prewarming will be applied following routine clinical practice. The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.
Who may be able to join
- Patients undergoing elective Transurethral resection under general or spinal anesthesia.
Who cannot join
- 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.
About this study
Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as myocardial ischemia or perioperative bleeding. 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. Once the temperature has decreased, its treatment is difficult. 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 if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to transurethral resection. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to undergo elective transurethral resection between March 2014 and April 2018. Three-hundred patients are included in this study and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. 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 study is justified.
- Conditions
- Hypothermia; Anesthesia, Peroperative Complication
- Being tested
- WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
- Keywords
- Prewarming, Tympanic temperature
- Medical subject headings
- Hypothermia, Intraoperative Complications
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 following routine clinical practice. The pre-warming time will depend on the time the patient has to wait before entering in the operating room. Prewarming time will be recorded for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Prewarming | Active Prewarming will be performed 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 warmed using a surgical blanket 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 | |
| Control | Non-active prewarming. Patients will be warmed using a surgical blanket 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Asses the effect of prewarming in maintaining body temperature of patients undergoing elective transurethral resection.
Measured: Through patient's stay in hospital, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study startMar 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 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
- Aurelio Rodríguez-Pérez, MD PhD, Study director, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527329
- Sponsor's protocol ID
- NAC120300
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 17 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
PubMed 26775126NICE. Inadvertent Perioperative Hypothermia: The Management of Inadvertent Perioperative Hypothermia in Adults. NICE Clinical Guideline No. 65, 2008.
Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006. No abstract available.
PubMed 21126665Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
PubMed 25837741Forbes SS, Eskicioglu C, Nathens AB, Fenech DS, Laflamme C, McLean RF, McLeod RS; Best Practice in General Surgery Committee, University of Toronto. Evidence-based guidelines for prevention of perioperative hypothermia. J Am Coll Surg. 2009 Oct;209(4):492-503.e1. doi: 10.1016/j.jamcollsurg.2009.07.002. Epub 2009 Aug 20. No abstract available.
PubMed 19801323
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hypothermia in Patients Submitted to Transurethral Resection
- ClinicalTrials.gov ID
- NCT03527329
- Acronym / sponsor ID
- NAC120300
- Conditions
- Hypothermia; Anesthesia, Peroperative Complication
- Keywords
- Prewarming, Tympanic temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Collaborators
- University of Las Palmas de Gran Canaria
- Study start
- Mar 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 May 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. Its appearance can have deleterious effects such as myocardial ischemia or perioperative bleeding. 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. Once the temperature has decreased, its treatment is difficult. 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 if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to transurethral resection. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to undergo elective transurethral resection between March 2014 and April 2018. Three-hundred patients are included in this study and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. 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 study is justified.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prewarming | – | Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USAActive Prewarming will be performed 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 warmed using a surgical blanket 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. |
| Control | – | –Non-active prewarming. Patients will be warmed using a surgical blanket 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
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to undergo elective transurethral resection between March 2014 and April 2018. Three-hundred patients are included in this study and prewarming will be applied following routine clinical practice. The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.
Key inclusion criteria (1 listed)
- Patients undergoing elective Transurethral resection under general or spinal anesthesia.
Key exclusion criteria (7 listed)
- Active infection
- Intake of antipyretics within 24 hours before surgery
- Neuropathy
- Thyroid disorders
- Peripheral vascular disease
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 following routine clinical practice. The pre-warming time will depend on the time the patient has to wait before entering in the operating room. Prewarming time will be recorded for each patient. | Device | Prewarming |
Primary outcome
Temperature
Time frame: Through patient's stay in hospital, an average of 24 hours
Asses the effect of prewarming in maintaining body temperature of patients undergoing elective transurethral resection.
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 17 May 2018.
- Background: PubMed 26775126Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
- BackgroundNICE. Inadvertent Perioperative Hypothermia: The Management of Inadvertent Perioperative Hypothermia in Adults. NICE Clinical Guideline No. 65, 2008.
- Background: PubMed 21126665Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006. No abstract available.
- Background: PubMed 25837741Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
- Background: PubMed 19801323Forbes SS, Eskicioglu C, Nathens AB, Fenech DS, Laflamme C, McLean RF, McLeod RS; Best Practice in General Surgery Committee, University of Toronto. Evidence-based guidelines for prevention of perioperative hypothermia. J Am Coll Surg. 2009 Oct;209(4):492-503.e1. doi: 10.1016/j.jamcollsurg.2009.07.002. Epub 2009 Aug 20. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Aurelio Rodríguez-Pérez, MD PhD study director
Hospital Universitario de Gran Canaria Doctor Negrín
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia; Anesthesia and Peroperative Complication, run by Hospital Universitario de Gran Canaria Doctor Negrín.
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 1 inclusion and 7 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Temperature (time frame: Through patient's stay in hospital, an average of 24 hours). 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 NCT03527329, which also lists 5 linked publications.
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 17 May 2018.