Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

Hypothermia Clinical Trial

Official title:

Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05302323
• Other study ID #: Interventional
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

Other:
• Disposable Drape
Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery
• Reusable Drape
Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Locations

Country	Name	City	State
Turkey	Gulhane training and research hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Neslihan Ilkaz

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

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. — View Citation

Guideline Quick View: Hypothermia. AORN J. 2019 Oct;110(4):463-465. doi: 10.1002/aorn.12843. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tympanic and esophageal body temperature measurement between two groups	Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.	throughout the operation (min.2 hours) (max. 6 hours)