Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Other: Reusable Drape; Other: Disposable Drape

• Registration Number: NCT05302323
• Lead Sponsor: Neslihan Ilkaz

Brief Summary

This study was planned to investigate whether the wetness of surgical drapes (disposable and resusable drapes) used in the intraoperative period causes hypothermia.

Detailed Description

After being informed about the study and potential risk all patients giving written informed consent then the study started. Patients who will undergo elective, gastrointestinal and other major abdominal surgery were included in the study. After patients were randomized by the investigator, patients were covered with disposable or reusable surgical drapes in accordance with hospital procedure. The body temperatures of the patients were followed for 2-6 hours as tympanic and esophageal. In addition, pre- and postoperative surgical drapes, sponges, compresses were measured with precision scales.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-11-30
• Study Completion: 2021-06-30
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• ASA 1-2-3
• Patients with abdominal surgery
• Patients receiving general anesthesia

Exclusion Criteria

• Unwanted to participate in the study
• Patients over 70 years of age
• Presence of central (high) fever originating from the central nervous system resulting from conditions such as cerebrovascular disease, cerebral trauma, intracranial surgery, epilepsy or acute hydrocephalus
• Abnormalities of thermoregulation such as hypothyroidism, hyperthyroidism, history of malignant hyperthermia, or neuroleptic malignant syndrome
• Presence of infectious fever
• ASA 4 and above
• Emergency surgery
• Patients receiving pre-operative chemotherapy
• Having problems such as tearing and perforation of the covers during the work.
• Patients being hyperthermic in the intraoperative process

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reusable Drapes	Reusable Drape	group using reusable surgical drapes
Disposable Drapes	Disposable Drape	group using disposable surgical drapes

Primary Outcome Measures

Name	Time	Method
tympanic and esophageal body temperature measurement between two groups	throughout the operation (min.2 hours) (max. 6 hours)	Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.

Trial Locations

Locations (1)

Gulhane training and research hospital; 🇹🇷 Ankara, Keçiören, Turkey