Effect of Reflective Blanket on Undesirable Perioperative Hypothermia

NCT05702320 | Unknown DMC

• 1 other identifier: 2021/041
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of using reflective blankets, which is a passive insulation product, on preventing UPH in patients scheduled for abdominal surgery under general anesthesia. It will also be evaluated whether the reflective blanket has an effect on the patients' thermal comfort and shivering levels. Inconsistent results have been reported in studies using reflective blankets. This inconsistency may be due to the fact that it was used at different stages of the perioperative process or that the body was not adequately isolated. In this study, we aimed to use the reflective blanket throughout the perioperative process and to isolate the patient's body as much as possible. Reflective blankets are inexpensive, practical to use and easy to store. With the positive results that can be obtained from this study, it can be used not only in operating rooms, but also in intensive care or other services where hypothermia is likely to occur. Within the scope of the study, a Reference group (warm air blower device), an Intervention group (reflective blanket) and a Control group (routine hospital procedure) will be established. The study was planned to be conducted with a total of 102 patients, with 34 patients in each group. In this study; patients' vital signs, coagulation tests, thermal comfort and shivering levels will be evaluated. Patients in the Reference and Intervention group will be warmed before the surgery (15 minutes), during the surgery, and until they are transferred from the post-anaesthetic care unit to the clinic. No heating process will be applied to the control group by the researcher. All patients transferred to the clinic will undergo the routine care procedure of the hospital.

Conditions

Abdominal Surgery; General Anesthesia; General Surgery

Keywords

unwanted perioperative hypothermia; reflective blanket; general anesthesia; Abdominal surgery

Outcome Measures

Primary Outcomes (3)

• Does the application of passive insulation with a reflective blanket during the perioperative process reduce the incidence of unwanted Perioperative Hypothermia in patients?

  Passive heating will be applied with a reflective blanket, body temperatures will be measured and the results will be recorded.

  12 months

• Does the application of passive insulation with a reflective blanket during the perioperative process reduce the incidence of tremors in patients?

  Passive heating will be applied with a reflective blanket, the tremor status of the patients will be measured with the tremor level assessment form and the results will be recorded.

  12 months

• Does the application of passive insulation with a reflective blanket during the perioperative period increase the level of thermal comfort perception in patients?

  Passive heating will be applied with a reflective cover, the thermal comfort levels of the patients will be measured with a thermal comfort perception assessment form and the results will be recorded.

  12 months

Study Arms (3)

Reference Group

EXPERIMENTAL

Patients in this group will be warmed for 15 minutes with a full-body blanket belonging to the air-blown heater device before surgery. The heating will be Decelerated until he is taken to the operating table, and after the preparations are completed, the lower extremities will continue to be heated with a half-body blanket belonging to the heating device. After the patient is taken to the post-anesthesia care unit, the soaked blankets will be removed and the whole body will continue to be warmed with a blanket as in the preoperative period. When the patient's body temperature rises above 36 °C, the heating process will be terminated and when he meets the criteria for being transferred to the clinic, his transfer to the clinic will be provided in accordance with the institution's policy.

Other: the heating procedure

intervention group

EXPERIMENTAL

The patients in this group will be wrapped with a reflective blanket from the neck to the whole body with the reflective side facing the patient for 15 minutes before the operation, so that only the surgical gown is on the patients in this group. After a layer of operating room cover is placed on the patient's lower extremities on the operating table in accordance with the hospital procedure, a reflective blanket will be wrapped on it with the reflective side facing the patient. After the patient is taken to the post-anesthesia care unit, the soaked covers will be removed and the entire body of the patient will be wrapped with a reflective blanket, as in the preoperative period. When the patient's body temperature rises above 36 °C and he meets the criteria for being transferred to the clinic, his transfer to the clinic will be provided in accordance with the institution's policy.

Other: the heating procedure

control group

NO INTERVENTION

No heating procedure will be performed by the researcher in this group of patients during the perioperative period, only the number of covers provided for heating in the post-anesthesia care unit will be recorded. The duration of stay in the post-anesthesia care unit, the transfer of the patient to the clinic and the follow-up in the clinic will be carried out according to the hospital procedure.

Interventions

the heating procedure OTHER

The patients will undergo a heating procedure.

Reference Group; intervention group

Eligibility Criteria

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

You may qualify if:

• abdominal surgery is planned,
• ASA I-II patients,
• who will undergo general anesthesia,
• operations where the anesthesia time is expected to take 30-120 minutes
• the age of 18,
• with a body mass index of 18.5-35 kg/m2,
• who can read and write,
• who participate voluntarily.

You may not qualify if:

• Patients who used any corticosteroids or other immunosuppressive drugs four weeks before surgery,
• Patients with a recent history of fever and/or infection,
• Patients with hypopituiterism,
• Patients taking antipsychotics and antidepressants,
• Patients with diabetic neuropathy,
• Active otitis media patients

Sponsors & Collaborators

• Öğr. Gör. Ali GÜZEL: lead
• Hasan Kalyoncu University: collaborator

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Ali GÜZEL

CONTACT

+905056239476; aliguzel6513@gmail.com

Ayla YAVA

CONTACT

+905372419171; ayla.yava@hku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: randomized controlled experimental research

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 27, 2023
• Study Start: February 14, 2022
• Primary Completion: February 14, 2023
• Study Completion: June 15, 2023
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)