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Effects of Active Prewarming in Perioperative Hypothermia in Adults

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Forced air warming devices

About this trial

This is an interventional prevention trial for Hypothermia; Anesthesia focused on measuring Active preoperative warming, Inadvertent hypothermia, Perioperative hypothermia, Surgical prewarming, Forced air warming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Universitario de Torrejon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prewarming

No prewarming

Arm Description

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

Non active warming is allowed before surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Hospital stay

Patient´s days keep in hospital, from admission in hospital until discharge from the home

Surgical site infection

Follow-up the wound and evaluation of signs and symptoms of surgical site infection from surgery to review for the nurse.

Prewarming duration

Time from pre-warming initiation in pre operative area with forced air warming device until transfer to operating theatre.

Full Information

NCT ID

NCT04033900

First Posted

June 19, 2019

Last Updated

July 15, 2021

Sponsor

RECIO PÉREZ, JESÚS

Collaborators

University of Alcala

1. Study Identification

Unique Protocol Identification Number

NCT04033900

Brief Title

Effects of Active Prewarming in Perioperative Hypothermia in Adults

Official Title

Effect of Active Warming Prior to Surgery in Perioperative Hypothermia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

RECIO PÉREZ, JESÚS

Collaborators

University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prewarming

Arm Type

Experimental

Arm Description

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

Arm Title

No prewarming

Arm Type

No Intervention

Arm Description

Non active warming is allowed before surgery

Intervention Type

Device

Intervention Name(s)

Forced air warming devices

Other Intervention Name(s)

Outpatient Warming Blanket Model 11101 Bair Hugger 3M, BAir Hugger Warming Unit Model 775 3M

Intervention Description

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

Primary Outcome Measure Information:

Title

Perioperative hypothermia

Description

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

Time Frame

From 1 hour to 12 hours

Secondary Outcome Measure Information:

Title

Hypothermia duration

Description

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.

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.

Title

Hospital stay

Description

Patient´s days keep in hospital, from admission in hospital until discharge from the home

Time Frame

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

Title

Surgical site infection

Description

Follow-up the wound and evaluation of signs and symptoms of surgical site infection from surgery to review for the nurse.

Time Frame

1 Month

Title

Prewarming duration

Description

Time from pre-warming initiation in pre operative area with forced air warming device until transfer to operating theatre.

Time Frame

From 10 minutes to 1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JESÚS RECIO PÉREZ, ANESTHETIST

Organizational Affiliation

HOSPITAL UNIVERSITARIO DE TORREJON

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario de Torrejon

City

Torrejon de ardoz

State/Province

Madrid

ZIP/Postal Code

28850

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

25411963

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.

Results Reference

background

PubMed Identifier

28454611

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.

Results Reference

background

PubMed Identifier

27098439

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.

Results Reference

background

PubMed Identifier

25837741

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.

Results Reference

background

PubMed Identifier

17004666

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.

Results Reference

background

PubMed Identifier

24075332

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.

Results Reference

background

PubMed Identifier

22376088

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.

Results Reference

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Effects of Active Prewarming in Perioperative Hypothermia in Adults

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