Hypothermia; AnesthesiaNCT04033900
Effects of Active Prewarming in Perioperative Hypothermia in Adults
A study testing Forced air warming devices in people with Hypothermia; Anesthesia and Hypothermia Due to Anesthetic, run by RECIO PÉREZ, JESÚS at 1 site in Spain.
Trial summary
This study evaluates the effect of active prewarming on the frequency and duration of perioperative hypothermia. 50% of patients will receive active warming with forced-air devices prior to entering the operating room, and the other 50% will not receive any active heating measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia; Anesthesia, Hypothermia Due to Anesthetic, Hypothermia Following Anesthesia
- What is being tested?
- Forced air warming devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2018to 31 Dec 2019
- 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
- > 18 years old.
- American Society of Anesthesiologists I-III.
- Undergoing surgery under general or locoregional anesthesia lasting more than 30 minutes.
- General surgery: hernias, cholecystectomies, hepatectomies, intestinal resections, pancreatoduodenectomies ...
- Traumatology and orthopedics: total / partial knee prosthesis, total / partial hip prosthesis, osteosynthesis, removal of material, arthroscopies, hallux valgus, lumbar arthrodesis ...
- Neurosurgery: lumbar arthrodesis, excision of intracranial tumors.
Show all 12Show fewer
- Gynecology: Hysterectomies, adnexectomies, hysteroscopy ...
- Otorhinolaryngology: septoplasty, nasosinusal endoscopic surgery, tonsillectomies, adenoidectomies, thyroidectomies...
- Thoracic: Pneumonectomies and pulmonary resections, sympathectomies, thoracoscopy ...
- Urology: Bladder transurethral resection , prostate transurethral resection, nephrectomies.
- Maxillofacial: parathyroidectomies, microsurgery ...
- Ability to understand the study, give authorization and collaborate with data collection
Who cannot join
- Local anesthesia or peripheral nerve block.
- Urgent or emergent surgery.
- Cognitive impairment or lack of collaboration of any kind
- Pregnant women undergoing cesarean section.
- Diabetes Mellitus poorly controlled (HbA1c> 6.5-7%)
- Subjects that are under treatment with drugs that interfere with thermoregulation or may cause drug-induced hyperthermia (amphetamines, barbiturates, inhaled gases ...)
Show all 10Show fewer
- Subjects with burns, pressure ulcers and other surface disturbances that cover the heating devices
- Subjects with screening temperature > 37.5º C.
- Subjects with fever or active infections.
- Subjects with chronic anemia who require periodic transfusions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Active Warming Prior to Surgery in Perioperative Hypothermia
This study evaluates the effect of active prewarming on the frequency and duration of perioperative hypothermia. 50% of patients will receive active warming with forced-air devices prior to entering the operating room, and the other 50% will not receive any active heating measures.
Read the detailed description
Inadvertent perioperative hypothermia is defined as a body temperature below 36º C during the perioperative period. It occurs as a result of the effects of anesthetic drugs on the regulation of body temperature and exposure to a cold environment.
The main temperature loss during the perioperative period occurs during the first hour after the anesthetic induction as a result of heat redistribution from the central compartment to the peripheral compartment
The most effective strategy to prevent perioperative hypothermia is the use of forced-air warming devices. These devices are usually initiated once the patient enters the operating room. At that time, the patient has already initiated the heat loss by distributing heat from the central to the peripheral compartment to maintain body temperature.
We intend to use forced-air warming devices before the patients is transferred to the operating room in order to preserve the peripheral body temperature. This way the redistribution of heat should be avoided and, therefore, perioperative hypothermia and its harmful effects will be prevented.
- Conditions
- Hypothermia; Anesthesia, Hypothermia Due to Anesthetic, Hypothermia Following Anesthesia, Hypothermia Following Anesthesia, Sequela
- Being tested
- Forced air warming devices
- Keywords
- Active preoperative warming, Inadvertent hypothermia, Perioperative hypothermia, Surgical prewarming, Forced air warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced air warming devicesDevice
Also called Outpatient Warming Blanket Model 11101 Bair Hugger 3M, BAir Hugger Warming Unit Model 775 3M
In the treatment group, heating will be started with a pre-surgical forced-air blanket "Outpatient Warming Blanket model 11101 Bair Hugger from 3M" and a forced-air heating unit "Bair Hugger Warming Unit Model 775 from 3M" at 38-43º C which will be maintain during the stay in the pre-surgery room until the transfer to the operating room
| Study group | Role | What they receive |
|---|---|---|
| Prewarming | Experimental | Active warming is allowed prior to surgery with forced-air warming devices Receives: Device: Forced air warming devices |
| No prewarming | No intervention | Non active warming is allowed before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative hypothermia
Core temperature below 36º C measured with 3M Spot On monitor every 5 minutes from arrival to the pre-surgical area, during surgery and unit discharge to the ward
Measured: From 1 hour to 12 hours
Secondary outcomes (4)
Hypothermia duration
Time of core temperature below 36º C measured every 5 minutes with 3M Spot On monitor from arrival to the surgery room and unit discharge to postoperative unit.
Measured: Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.
Hospital stay
Patient´s days keep in hospital, from admission in hospital until discharge from the home
Measured: From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.
Surgical site infection
Follow-up the wound and evaluation of signs and symptoms of surgical site infection from surgery to review for the nurse.
Measured: 1 Month
Prewarming duration
Time from pre-warming initiation in pre operative area with forced air warming device until transfer to operating theatre.
Measured: From 10 minutes to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECIO PÉREZ, JESÚS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala
- Responsible party
- Sponsor-investigator, RECIO PÉREZ, JESÚS, University of Alcala
- Investigators
- JESÚS RECIO PÉREZ, ANESTHETIST, Principal investigator, HOSPITAL UNIVERSITARIO DE TORREJON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033900
- Sponsor's protocol ID
- 200230
- Status last verified
- Jul 2021
- First submitted
- 19 Jun 2019
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Warttig S, Alderson P, Campbell G, Smith AF. Interventions for treating inadvertent postoperative hypothermia. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD009892. doi: 10.1002/14651858.CD009892.pub2.
PubMed 25411963Giuliano KK, Hendricks J. Inadvertent Perioperative Hypothermia: Current Nursing Knowledge. AORN J. 2017 May;105(5):453-463. doi: 10.1016/j.aorn.2017.03.003.
PubMed 28454611Madrid E, Urrutia G, Roque i Figuls M, Pardo-Hernandez H, Campos JM, Paniagua P, Maestre L, Alonso-Coello P. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016 Apr 21;4(4):CD009016. doi: 10.1002/14651858.CD009016.pub2.
PubMed 27098439Torossian 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 25837741Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3.
PubMed 17004666Kellam MD, Dieckmann LS, Austin PN. Forced-air warming devices and the risk of surgical site infections. AORN J. 2013 Oct;98(4):354-66; quiz 367-9. doi: 10.1016/j.aorn.2013.08.001.
PubMed 24075332Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.
PubMed 22376088
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active Warming Prior to Surgery in Perioperative Hypothermia
- ClinicalTrials.gov ID
- NCT04033900
- Acronym / sponsor ID
- 200230
- Conditions
- Hypothermia; Anesthesia, Hypothermia Due to Anesthetic, Hypothermia Following Anesthesia, Hypothermia Following Anesthesia, Sequela
- Keywords
- Active preoperative warming, Inadvertent hypothermia, Perioperative hypothermia, Surgical prewarming, Forced air warming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- RECIO PÉREZ, JESÚSUniversity, hospital or other
- Collaborators
- University of Alcala
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jul 2019 (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.
This study evaluates the effect of active prewarming on the frequency and duration of perioperative hypothermia. 50% of patients will receive active warming with forced-air devices prior to entering the operating room, and the other 50% will not receive any active heating measures.
Detailed description
Inadvertent perioperative hypothermia is defined as a body temperature below 36º C during the perioperative period. It occurs as a result of the effects of anesthetic drugs on the regulation of body temperature and exposure to a cold environment.
The main temperature loss during the perioperative period occurs during the first hour after the anesthetic induction as a result of heat redistribution from the central compartment to the peripheral compartment
The most effective strategy to prevent perioperative hypothermia is the use of forced-air warming devices. These devices are usually initiated once the patient enters the operating room. At that time, the patient has already initiated the heat loss by distributing heat from the central to the peripheral compartment to maintain body temperature.
We intend to use forced-air warming devices before the patients is transferred to the operating room in order to preserve the peripheral body temperature. This way the redistribution of heat should be avoided and, therefore, perioperative hypothermia and its harmful effects will be prevented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prewarming | Experimental | Device: Forced air warming devicesActive warming is allowed prior to surgery with forced-air warming devices |
| No prewarming | No intervention | –Non active warming is allowed before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- > 18 years old.
- American Society of Anesthesiologists I-III.
- Undergoing surgery under general or locoregional anesthesia lasting more than 30 minutes.
- General surgery: hernias, cholecystectomies, hepatectomies, intestinal resections, pancreatoduodenectomies ...
- Traumatology and orthopedics: total / partial knee prosthesis, total / partial hip prosthesis, osteosynthesis, removal of material, arthroscopies, hallux valgus, lumbar arthrodesis ...
Key exclusion criteria (10 listed)
- Local anesthesia or peripheral nerve block.
- Urgent or emergent surgery.
- Cognitive impairment or lack of collaboration of any kind
- Pregnant women undergoing cesarean section.
- Diabetes Mellitus poorly controlled (HbA1c> 6.5-7%)
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 |
|---|---|---|
| Forced air warming devicesAlso: Outpatient Warming Blanket Model 11101 Bair Hugger 3M, BAir Hugger Warming Unit Model 775 3MIn the treatment group, heating will be started with a pre-surgical forced-air blanket "Outpatient Warming Blanket model 11101 Bair Hugger from 3M" and a forced-air heating unit "Bair Hugger Warming Unit Model 775 from 3M" at 38-43º C which will be maintain during the stay in the pre-surgery room until the transfer to the operating room | Device | Prewarming |
Primary outcome
Perioperative hypothermia
Time frame: From 1 hour to 12 hours
Core temperature below 36º C measured with 3M Spot On monitor every 5 minutes from arrival to the pre-surgical area, during surgery and unit discharge to the ward
4 secondary outcomes
Hypothermia duration
Time frame: Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.
Hospital stay
Time frame: From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.
Surgical site infection
Time frame: 1 Month
Prewarming duration
Time frame: From 10 minutes to 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 22 Jul 2021.
- Background: PubMed 25411963Warttig S, Alderson P, Campbell G, Smith AF. Interventions for treating inadvertent postoperative hypothermia. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD009892. doi: 10.1002/14651858.CD009892.pub2.
- Background: PubMed 28454611Giuliano KK, Hendricks J. Inadvertent Perioperative Hypothermia: Current Nursing Knowledge. AORN J. 2017 May;105(5):453-463. doi: 10.1016/j.aorn.2017.03.003.
- Background: PubMed 27098439Madrid E, Urrutia G, Roque i Figuls M, Pardo-Hernandez H, Campos JM, Paniagua P, Maestre L, Alonso-Coello P. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016 Apr 21;4(4):CD009016. doi: 10.1002/14651858.CD009016.pub2.
- 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 17004666Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3.
- Background: PubMed 24075332Kellam MD, Dieckmann LS, Austin PN. Forced-air warming devices and the risk of surgical site infections. AORN J. 2013 Oct;98(4):354-66; quiz 367-9. doi: 10.1016/j.aorn.2013.08.001.
- Background: PubMed 22376088Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.
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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.
JESÚS RECIO PÉREZ, ANESTHETIST principal investigator
HOSPITAL UNIVERSITARIO DE TORREJON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced air warming devices in people with Hypothermia; Anesthesia and Hypothermia Due to Anesthetic, run by RECIO PÉREZ, JESÚS 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 12 inclusion and 10 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 22 Jul 2021. 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?
Perioperative hypothermia (time frame: From 1 hour to 12 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 NCT04033900, which also lists 7 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 22 Jul 2021.