- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04033900
Effects of Active Prewarming in Perioperative Hypothermia in Adults
Effect of Active Warming Prior to Surgery in Perioperative Hypothermia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Torrejon de ardoz, Madrid, Spain, 28850
- Hospital Universitario de Torrejón
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- > 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.
- 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
Exclusion Criteria:
- 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 ...)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Prewarming
Active warming is allowed prior to surgery with forced-air warming devices
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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
Other Names:
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NO_INTERVENTION: No prewarming
Non active warming is allowed before surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative hypothermia
Time Frame: From 1 hour to 12 hours
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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
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From 1 hour to 12 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.
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Hospital stay
Time Frame: From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.
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Patient´s days keep in hospital, from admission in hospital until discharge from the home
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From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.
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Surgical site infection
Time Frame: 1 Month
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Follow-up the wound and evaluation of signs and symptoms of surgical site infection from surgery to review for the nurse.
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1 Month
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Prewarming duration
Time Frame: From 10 minutes to 1 hour
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Time from pre-warming initiation in pre operative area with forced air warming device until transfer to operating theatre.
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From 10 minutes to 1 hour
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: JESÚS RECIO PÉREZ, ANESTHETIST, Hospital Universitario de Torrejón
Publications and helpful links
General Publications
- Wagner 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.
- Warttig S, Alderson P, Campbell G, Smith AF. Interventions for treating inadvertent postoperative hypothermia. Cochrane Database Syst Rev. 2014 Nov 20;(11):CD009892. doi: 10.1002/14651858.CD009892.pub2.
- Giuliano 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.
- Madrid 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.
- Torossian 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.
- Kellam 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. Erratum In: AORN J. 2014 Sep;100(3):331.
- Horn 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200230
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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