NCT04907617

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bozok University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Nursing Caries
• Postoperative Pain
• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2020-12-18
• Primary completion: 2021-09-18
• Completion: 2021-12-18
• First posted: 2021-06-01
• Last updated: 2021-06-01

Locations

1 site across 1 country: Turkey (Türkiye)