Clinical trial NCT04033900: Effects of Active Prewarming in Perioperative Hypothermia in Adults
Official title: Effect of Active Warming Prior to Surgery in Perioperative Hypothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: University of Alcala
First posted: 2019-07-26
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative hypothermia
timeFrame: From 1 hour to 12 hours
Secondary outcomes:
measure: Hypothermia duration
timeFrame: Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.
measure: Hospital stay
timeFrame: From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.
measure: Surgical site infection
timeFrame: 1 Month
measure: Prewarming duration
timeFrame: From 10 minutes to 1 hour
Other outcomes:
Locations:
city: Torrejon de ardoz
country: Spain
facility: Hospital Universitario de Torrejon
state: Madrid
Study officials:
affiliation: HOSPITAL UNIVERSITARIO DE TORREJON
name: JESÚS RECIO PÉREZ, ANESTHETIST
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.