Effects of Active Prewarming in Perioperative Hypothermia in Adults

Hypothermia; Anesthesia Clinical Trial

Official title:

Effect of Active Warming Prior to Surgery in Perioperative Hypothermia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033900
• Other study ID #: 200230
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2021
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Due to Anesthetic
• Hypothermia Following Anesthesia
• Hypothermia Following Anesthesia, Sequela
• Hypothermia; Anesthesia

Intervention

Device:
• Forced air warming devices
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

Locations

Country	Name	City	State
Spain	Hospital Universitario de Torrejon	Torrejon de ardoz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
RECIO PÉREZ, JESÚS	University of Alcala

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

Horn EP, Bein B, Böhm R, Steinfath M, Sahili N, Höcker 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. — View Citation

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. — View Citation

Madrid E, Urrútia G, Roqué 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:CD009016. doi: 10.1002/14651858.CD009016.pub2. Review. — View Citation

Torossian A, Bräuer A, Höcker 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. — View Citation

Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From 1 hour to 12 hours
Secondary	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.	Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.
Secondary	Hospital stay	Patient´s days keep in hospital, from admission in hospital until discharge from the home	From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.
Secondary	Surgical site infection	Follow-up the wound and evaluation of signs and symptoms of surgical site infection from surgery to review for the nurse.	1 Month
Secondary	Prewarming duration	Time from pre-warming initiation in pre operative area with forced air warming device until transfer to operating theatre.	From 10 minutes to 1 hour