Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

• Sponsor: Neslihan Ilkaz (Other)
• Overall Status: Completed
• CT.gov ID: NCT05302323
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia	Other: Disposable Drape; Other: Reusable Drape	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: major abdominal surgerymajor abdominal surgery
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Disposable Drapes group using disposable surgical drapes	Other: Disposable Drape; Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery
Other: Reusable Drapes group using reusable surgical drapes	Other: Reusable Drape; Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane training and research hospital	Ankara	Keçiören	Turkey	06010

Sponsors and Collaborators

• Neslihan Ilkaz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Association of periOperative Registered Nurses. Recommended practices for selection and use of surgical gowns and drapes. AORN J. 2003 Jan;77(1):206-10, 213.
• Bashaw MA. Guideline Implementation: Preventing Hypothermia. AORN J. 2016 Mar;103(3):305-10; quiz 311-3. doi: 10.1016/j.aorn.2016.01.009.
• Guideline Quick View: Hypothermia. AORN J. 2019 Oct;110(4):463-465. doi: 10.1002/aorn.12843.
• Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006.
• Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia. J Perianesth Nurs. 2009 Oct;24(5):271-87. doi: 10.1016/j.jopan.2009.09.001. Erratum in: J Perianesth Nurs. 2010 Apr;25(2):111.
• Maglinger PE, Sessler DI, Lenhardt R. Cutaneous heat loss with three surgical drapes, one impervious to moisture. Anesth Analg. 2005 Mar;100(3):738-742. doi: 10.1213/01.ANE.0000143954.98285.63.
• NICE. Hypothermia: prevention and management in adults having surgery. Clinical guideline Published: 23 April 2008, Last Updated 2016, nice.org.uk/guidance/cg65
• NICE. Inadvertent perioperative hypothermia Overview. http://pathways.nice.org.uk/pathways/inadvertent-perioperative-hypothermia. 27.11.2017

• Responsible Party: Neslihan Ilkaz, Operating Room Nurse, PhD, RN, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• ClinicalTrials.gov Identifier: NCT05302323
• Other Study ID Numbers: Interventional
• First Posted: Mar 31, 2022
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Neslihan Ilkaz, Operating Room Nurse, PhD, RN, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: Hypothermia; perioperative nursing; operating room nursing; unintended hypothermia
• Additional relevant MeSH terms: Hypothermia

Study Results

No Results Posted as of Apr 14, 2022