Effects of Active Prewarming in Perioperative Hypothermia in Adults

Sponsor

RECIO PÉREZ, JESÚS (Other)

Overall Status

Completed

CT.gov ID

NCT04033900

Collaborator

University of Alcala (Other)

197

Enrollment

Location

Arms

Actual Duration (Months)

15.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia; Anesthesia Hypothermia Due to Anesthetic Hypothermia Following Anesthesia Hypothermia Following Anesthesia, Sequela	Device: Forced air warming devices	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

197 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Active Warming Prior to Surgery in Perioperative Hypothermia

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prewarming Active warming is allowed prior to surgery with forced-air warming devices	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 Other Names: Outpatient Warming Blanket Model 11101 Bair Hugger 3M BAir Hugger Warming Unit Model 775 3M
No Intervention: No prewarming Non active warming is allowed before surgery

Arm

Intervention/Treatment

Experimental: Prewarming

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

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

Other Names:

Outpatient Warming Blanket Model 11101 Bair Hugger 3M

BAir Hugger Warming Unit Model 775 3M

No Intervention: No prewarming

Non active warming is allowed before surgery

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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