The Effect of Active Warming During General Anaesthesia on Postoperative Body Temperature, Shivering and Thermal Comfort

The Effect of Active Warming During General Anaesthesia on Postoperative Body Temperature, Shivering, Thermal Comfort, Pain, Nausea and Vomiting in Adult Patients: A Randomised Controlled Trial Protocol

Adult patients who undergo surgery under general anaesthesia often experience inadvertent perioperative hypothermia. This common problem has serious consequences such as surgical site infection, coagulopathy, increased need for transfusion, altered drug metabolism and adverse cardiac events. Perioperative guidelines recommend warming the patient with a forced-air warming device and administering warmed intravenous and irrigation fluids to prevent intraoperative hypothermia. This study aims to investigate the effects of individual and combined use of intraoperative forced-air warming and warmed intravenous and irrigation fluids on postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Nursing Caries
• Intervention / Treatment: Other: FAW; Other: Warmed fluids; Other: Combination; Other: Control

Detailed Description

Background: Adult patients who undergo surgery under general anaesthesia often experience inadvertent perioperative hypothermia. This common problem has serious consequences such as surgical site infection, coagulopathy, increased need for transfusion, altered drug metabolism and adverse cardiac events. Perioperative guidelines recommend warming the patient with a forced-air warming device and administering warmed intravenous and irrigation fluids to prevent intraoperative hypothermia.

Objective: This study aims to investigate the effects of individual and combined use of intraoperative forced-air warming and warmed intravenous and irrigation fluids on postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.

Design and setting: This is a single centre randomised controlled clinical trial. A 2 x 2 factorial design will used in the experiment. Eligible patients will be randomly assigned to one of four groups.

Methods: After the induction of anaesthesia, forced-air warming as well as warmed intravenous (IV) and irrigation fluids will be applied to the first group, the second group will be warmed with only forced-air warming device, the third group will receive only warmed intravenous and irrigation fluids, and the fourth group will consist of the control group without any intervention. Blood and blood products to be applied intraoperatively to all groups will be heated to 37°C. The primary outcome measures are postoperative body temperature, shivering, thermal comfort, pain, nausea and vomiting. The primary results will be subjected to a two-way analysis of variance for covariants such as ambient temperature and volume of intraoperative fluids.

Participants: The trial will include patients aged ≥18 years who underwent surgery under general anaesthesia, whose duration of surgery was >1 hour, who belong to the class of American Society of Anesthesiologists I-III, who do not have any disability that would make communication difficult, and who provide written informed consent to participate in the study.

Discussion: The trial is designed to validate the effectiveness of these two interventions administered alone and in combination in maintaining perioperative normothermia and to assess whether they translate into improved patient outcomes.

* This trial is being carried out as Marmara University Institute of Health Sciences Doctorate Thesis in Nursing.

Funding: No funding

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yozgat, Turkey
    • Recruiting
    • Özlem
    • Contact: Özlem Şahin Akboğa; Phone Number: 5396848180; Email: ozlemsahin.os17@gmail.com
    • Principal Investigator: Aysel Gürkan, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Being over the age of 18 Receiving general anesthesia, surgery time ≥ 1 hour in the American Society of Anesthesiologists (ASA) I-III class Not having any obstacle to make communication difficult İnformed written consent to participate in the study.

Exclusion Criteria:

Having surgery with local anesthesia Preoperative body temperature ≥38 0C or <36 0C Unapplied therapeutic hypothermia during the operation, Systemic infection in the patient, Mental retardation, Serious head injury, Brain damage disruption in temperature regulation, Taking medication to affect thermoregulation Unapplied IV fluids up to one hour before anesthesia induction.

Exclusion criteria is exitus and worsening for any reason in the general condition during and after the surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G1; After the induction of anaesthesia, the first group will be heated with only forced-air warming device.	Other: FAW; After the induction of anaesthesia, for patients assigned to groups 1 and 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C.
Experimental: G2; After the induction of anaesthesia, the second group will receive only warmed IV and irrigation fluids.	Other: Warmed fluids; In patients assigned to groups 2 and 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet.
Experimental: G3; After the induction of anaesthesia, forced-air warming as well as warmed IV and irrigation fluids will be applied to the third group	Other: Combination; After the induction of anaesthesia, for patients assigned to groups 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C. In patients assigned to groups 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet.
Experimental: G4; After the induction of anaesthesia, the fourth group will be the control group without any intervention.	Other: Control; The patients assigned to group 4 will only receive 'routine care'. They will not be given intraoperative forced-air warming or heated IV and irrigation fluids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature	In the trial, the body temperature of the participants will be measured with a tympanic thermometer (Braun ThermoScan® 3, IRT 3030, Mexico, USA).	two days
Thermal comfort scale	The thermal comfort of the patients will be measured with a 100-point thermal comfort scale based on self-reporting. The patients will be asked to score how comfortable they are with their body temperature [0 = extremities too cold; 50 = no discomfort (shivering or sweating); 100 = extremities too hot] on a scale of 0-100 points (Cobb et al., 2016). This numerical rating scale has been used effectively in previous studies on thermal comfort	two days
Shivering	Shivering will be assessed using a 4-point bedside shivering assessment scale developed by Badjatia et al. (2008) [0 = no shivering; 1 = mild (shivering localised in the neck/thorax, only visible as an artefact on EEG or can be noted on palpation); 2 = moderate (intermittent shivering in the upper extremities ± thorax); 3 = severe (diffuse shivering or continuous shivering in the upper/lower extremities)]	two days
Postoperative pain	The postoperative pain of the patients will be assessed with the Numerical Rating Scale (NRS) based on self-reporting. The obtained NRS score will be considered as 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain (Chou et al., 2016; Van Dijk et al., 2012).	two days
Postoperative nausea and vomiting	Based on a previous study, the presence of postoperative nausea and vomiting of the patients in the trial will be considered as follows: 0 = no nausea; 1 = nausea without vomiting; 2 = nausea with vomiting.	two

Collaborators and Investigators

• Sponsor: Bozok University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): September 18, 2021
• Study Completion (Anticipated): December 18, 2021

Study Registration Dates

• First Submitted: May 22, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Postoperative Nausea and Vomiting; Hypothermia; Body Temperature; Shivering; Perioperative Nursing
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: marmarabozok

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: It is not suitable for making individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No