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

NCT04907617 | Unknown

• 1 other identifier: marmarabozok
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nursing Caries; Postoperative Pain; Postoperative Nausea and Vomiting

Keywords

Perioperative Nursing; Body Temperature; Hypothermia; Shivering; Pain; Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

G1

EXPERIMENTAL

After the induction of anaesthesia, the first group will be heated with only forced-air warming device.

Other: FAW

G2

EXPERIMENTAL

After the induction of anaesthesia, the second group will receive only warmed IV and irrigation fluids.

Other: Warmed fluids

G3

EXPERIMENTAL

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

G4

EXPERIMENTAL

After the induction of anaesthesia, the fourth group will be the control group without any intervention.

Other: Control

Interventions

FAW OTHER

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.

G1

Warmed fluids OTHER

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.

G2

Combination OTHER

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.

G3

Control OTHER

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.

G4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Özlem

Yozgat, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Sahin Akboga O, Gurkan A. Effects of Active Heating Methods on Body Temperature, Shivering, Thermal Comfort, Pain, Nausea and Vomiting During General Anesthesia: A Randomized Controlled Trial. Ther Hypothermia Temp Manag. 2024 Dec;14(4):269-281. doi: 10.1089/ther.2023.0049. Epub 2023 Nov 24.

  PMID: 38011688 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Hypothermia; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Body Temperature Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be blinded to the trial hypothesis and design to avoid being affected by the warming intervention.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Model Details: The participants in the study will be allocated to one of four groups. In the trial, the participants will be assigned to the interventions and registered by the first author of this study.After the induction of anaesthesia, forced-air warming as well as warmed IV and irrigation fluids will be applied to the first group, the second group will be heated with only forced-air warming device, the third group will receive only warmed IV and irrigation fluids, and the fourth group will be the control group without any intervention.

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 1, 2021
• Study Start: December 18, 2020
• Primary Completion: September 18, 2021
• Study Completion: December 18, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)