NCT04033900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

June 19, 2019

Last Update Submit

July 15, 2021

Conditions

Hypothermia; AnesthesiaHypothermia Due to AnestheticHypothermia Following AnesthesiaHypothermia Following Anesthesia, Sequela

Keywords

Active preoperative warmingInadvertent hypothermiaPerioperative hypothermiaSurgical prewarmingForced air warming

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hypothermia duration

    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

    From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.

  • Surgical site infection

    1 Month

  • Prewarming duration

    From 10 minutes to 1 hour

Study Arms (2)

Prewarming

EXPERIMENTAL

Active warming is allowed prior to surgery with forced-air warming devices

Device: Forced air warming devices

No prewarming

NO INTERVENTION

Non active warming is allowed before surgery

Interventions

Forced air warming devicesDEVICE

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

Also known as: Outpatient Warming Blanket Model 11101 Bair Hugger 3M, BAir Hugger Warming Unit Model 775 3M
Prewarming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Related Publications (7)

  • 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.

    PMID: 25411963BACKGROUND

  • 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.

    PMID: 28454611BACKGROUND

  • 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.

    PMID: 27098439BACKGROUND

  • 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.

    PMID: 25837741BACKGROUND

  • 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.

    PMID: 17004666BACKGROUND

  • 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.

    PMID: 24075332BACKGROUND

  • 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.

    PMID: 22376088BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JESÚS RECIO PÉREZ, ANESTHETIST

    HOSPITAL UNIVERSITARIO DE TORREJON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ANESTHESIOLOGIST

Study Record Dates

First Submitted

June 19, 2019

First Posted

July 26, 2019

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 31, 2019

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

ES(1)