Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

NCT ID: NCT05302323

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

major abdominal surgery
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Disposable Drapes

group using disposable surgical drapes

Group Type OTHER

Disposable Drape

Intervention Type OTHER

Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Reusable Drapes

group using reusable surgical drapes

Group Type OTHER

Reusable Drape

Intervention Type OTHER

Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Interventions

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Disposable Drape

Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Intervention Type OTHER

Reusable Drape

Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neslihan Ilkaz

OTHER

Sponsor Role lead

Responsible Party

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Neslihan Ilkaz

Operating Room Nurse, PhD, RN

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gulhane training and research hospital

Ankara, Keçiören, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 19853810 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 21126665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26924369 (View on PubMed)

NICE. Hypothermia: prevention and management in adults having surgery. Clinical guideline Published: 23 April 2008, Last Updated 2016, nice.org.uk/guidance/cg65

Reference Type BACKGROUND

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. doi: 10.1016/s0001-2092(06)61392-6. No abstract available.

Reference Type BACKGROUND
PMID: 12575635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15728062 (View on PubMed)

NICE. Inadvertent perioperative hypothermia Overview. http://pathways.nice.org.uk/pathways/inadvertent-perioperative-hypothermia. 27.11.2017

Reference Type BACKGROUND

Guideline Quick View: Hypothermia. AORN J. 2019 Oct;110(4):463-465. doi: 10.1002/aorn.12843. No abstract available.

Reference Type BACKGROUND
PMID: 31560431 (View on PubMed)

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id

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