NCT05302323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

March 21, 2022

Last Update Submit

April 6, 2022

Conditions

Hypothermia

Keywords

Hypothermiaperioperative nursingoperating room nursingunintended hypothermia

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Disposable Drapes

OTHER

group using disposable surgical drapes

Other: Disposable Drape

Reusable Drapes

OTHER

group using reusable surgical drapes

Other: Reusable Drape

Interventions

Disposable DrapeOTHER

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

Disposable Drapes
Reusable DrapeOTHER

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

Reusable Drapes

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane training and research hospital

Ankara, Keçiören, 06010, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 19853810BACKGROUND

  • 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.

    PMID: 21126665BACKGROUND

  • 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.

    PMID: 26924369BACKGROUND

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

    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.

    PMID: 12575635BACKGROUND

  • 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.

    PMID: 15728062BACKGROUND

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

    BACKGROUND

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

    PMID: 31560431BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: major abdominal surgery
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Operating Room Nurse, PhD, RN

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

April 1, 2019

Primary Completion

November 30, 2020

Study Completion

June 30, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

TU(1)