The Effect of Preoperative Active Warming on Intraoperative Body Temperature

NCT05334589 | Completed

• 1 other identifier: ErsoyU
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled study was conducted to examine the effect of active warming before total knee arthroplasty on intraoperative body temperature and comfort.

Conditions

Total Knee Arthroplasty; Intraoperative Hypothermia

Keywords

Surgical nursing; Inadvertent hypothermia; Perioperative period; Active warming; Comfort

Outcome Measures

Primary Outcomes (1)

• Intraoperative body temperature

  During the operation, the body temperature of the patients will be measured at 15-minute intervals from the beginning of the incision to the end of the operation. Patients' body temperature will be measured tympanically using Braun ThermoScan® 7 Age Precision®.

  Throughout the operation (min.1 hours) (max. 2 hours)

Secondary Outcomes (7)

• Temperature comfort perception (before being sent to the operating room)

  Before being sent to the operating room (min.15 minutes) (max.45 minutes)

• Postoperative body temperature

  Until admission to the Postanaesthesia Care Unit and sent to the clinic (min.15 minutes) (max.30 minutes)

• Hemodynamic parameters (Blood pressure)

  From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)

• Hemodynamic parameters (pulse)

  From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)

• Hemodynamic parameters (oxygen saturation)

  From the beginning of the incision to the end of the surgery.(min.1 hours) (max. 2 hours)

Study Arms (2)

Experimental: Intervention group

EXPERIMENTAL

Patients in the intervention group will be prewarming with a hot air blowing system for 30 minutes before the operation. The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery.

Device: Prewarming

Control group

NO INTERVENTION

The patients will continue to be warmed with a carbon fiber heating bed, which is a resistive system, during the surgery.

Interventions

Prewarming DEVICE

When patients in the study group come to the Preoperative Care Unit (PCU), their body temperature will be measured. Patients in the study group will be placed in such a way that the 3M™ Bair Hugger™ Whole Body Blanket covers the patient's body and prewarmed with the 3M™ Bair Hugger™ Warming Unit for 30 minutes before anesthesia is given in the PCU. Heating unit temperature will be adjusted to 43°C in line with company recommendations. After the patients in the study group are warmed up for 30 minutes, the preheating process will be completed and the whole body blanket will be taken and the blankets that the clinic routinely use for each patient will be covered to cover the patients' body.

Experimental: Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who volunteered to participate in the study
• Elective surgery planned
• Patients between the ages of 18-80
• ASA I-III
• Neuroaxial anesthesia applied
• No sensory problems (hearing, vision)
• No psychiatric illness
• \<BMI\<39.9 kg/m2

You may not qualify if:

• Body temperature \<36°C at the entrance to the operating room
• Preoperative body temperature \<36°C
• Patients who develop complications during preheating (blood pressure rise, patients are uncomfortable with the heat, they are agitated)
• Peripheral vascular disease
• Patients with communication difficulties
• Patients with infectious disease

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Hatice Özsoy

Merkez, Burdur, Turkey (Türkiye)

Location

Related Publications (3)

• Akhtar Z, Hesler BD, Fiffick AN, Mascha EJ, Sessler DI, Kurz A, Ayad S, Saager L. A randomized trial of prewarming on patient satisfaction and thermal comfort in outpatient surgery. J Clin Anesth. 2016 Sep;33:376-85. doi: 10.1016/j.jclinane.2016.04.041. Epub 2016 Jun 3.

  PMID: 27555196 BACKGROUND

• Rosenkilde C, Vamosi M, Lauridsen JT, Hasfeldt D. Efficacy of Prewarming With a Self-Warming Blanket for the Prevention of Unintended Perioperative Hypothermia in Patients Undergoing Hip or Knee Arthroplasty. J Perianesth Nurs. 2017 Oct;32(5):419-428. doi: 10.1016/j.jopan.2016.02.007. Epub 2016 Dec 9.

  PMID: 28938977 BACKGROUND

• Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17.

  PMID: 27687449 BACKGROUND

Study Officials

• Hatice Özsoy, PhD Student

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Patients were divided into intervention and control groups using the block randomization method.

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 19, 2022
• Study Start: November 2, 2021
• Primary Completion: June 8, 2022
• Study Completion: July 29, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

TU (1)