The Effect of Preoperative Active Warming on Intraoperative Body Temperature

NCT ID: NCT05334589

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2022-07-29

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.

Detailed Description

Inadvertent perioperative hypothermia is defined as a patient's internal temperature below 36 °C in surgical settings. All patients undergoing surgery and other invasive procedures are at risk of developing undesirable hypothermia. Both general and neuraxial anesthesia greatly impair thermoregulatory control, and as a result, unwarmed surgical patients become hypothermic. General and regional anesthesia causes undesirable hypothermia as a result of the redistribution of body temperature from the center to the periphery.

In the perioperative period, patients over 60 years of age with poor nutritional status, low core temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, premedication, type of surgery, dry and cold anesthetic gases, cold intravenous fluids, flushes, blood products (cold fluids direct core temperature) Hypothermia is caused by low ambient temperature, wet skin, dressings or sheets, anesthetic agents, large open cavity or abdominal surgery, excessive blood loss, drugs used before surgery.

There are many methods to maintain the body temperature of patients (passive isolation methods) or to warm the patient (active warming methods). Passive insulation methods include heated cotton blankets, surgical drapes, and thermal suits. Active heating techniques include compressed air heaters, electric heating blankets, and heated liquids and gases.

In the literature, studies on active and passive heating methods have been found in order to prevent undesirable hypothermia. There are studies with stand-alone active heating methods (such as pressurized hot air blowing systems, heated liquids, circulating hot water systems) and combined methods. Because the results of these studies were different, a randomized controlled study was planned to investigate the effectiveness of the prewarming intervention, to support the surgical process nurses in clinical practice, and to increase the reliability of the results, before developing a procedure related to prewarming.

In the study, the effect of prewarming with a hot air blowing system before the surgical procedure on the patients who will undergo total knee arthroplasty, on the patient's body temperature during the operation and on the comfort in the early postoperative period will be determined.

Conditions

Total Knee Arthroplasty; Intraoperative Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental: Intervention group

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.

Group Type: EXPERIMENTAL

Prewarming

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prewarming

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 18.5<BMI<39.9 kg/m2

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Özsoy

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Özsoy, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Locations

Hatice Özsoy

Merkez, Burdur, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27555196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28938977 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27687449 (View on PubMed)

Other Identifiers

ErsoyU

Identifier Type: -

Identifier Source: org_study_id