Back to resultsEvaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
Primary Purpose
Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Disposable Drape
Reusable Drape
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring Hypothermia, perioperative nursing, operating room nursing, unintended hypothermia
Eligibility Criteria
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
Sites / Locations
- Gulhane training and research hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Disposable Drapes
Reusable Drapes
Arm Description
group using disposable surgical drapes
group using reusable surgical drapes
Outcomes
Primary Outcome Measures
tympanic and esophageal body temperature measurement between two groups
Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05302323
Brief Title
Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
Official Title
Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neslihan Ilkaz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Hypothermia, perioperative nursing, operating room nursing, unintended hypothermia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
major abdominal surgery
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Disposable Drapes
Arm Type
Other
Arm Description
group using disposable surgical drapes
Arm Title
Reusable Drapes
Arm Type
Other
Arm Description
group using reusable surgical drapes
Intervention Type
Other
Intervention Name(s)
Disposable Drape
Intervention Description
Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery
Intervention Type
Other
Intervention Name(s)
Reusable Drape
Intervention Description
Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery
Primary Outcome Measure Information:
Title
tympanic and esophageal body temperature measurement between two groups
Description
Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.
Time Frame
throughout the operation (min.2 hours) (max. 6 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gulhane training and research hospital
City
Ankara
State/Province
Keçiören
ZIP/Postal Code
06010
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
19853810
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. No abstract available. Erratum In: J Perianesth Nurs. 2010 Apr;25(2):111.
Results Reference
background
PubMed Identifier
21126665
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. No abstract available.
Results Reference
background
PubMed Identifier
26924369
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.
Results Reference
background
Citation
NICE. Hypothermia: prevention and management in adults having surgery. Clinical guideline Published: 23 April 2008, Last Updated 2016, nice.org.uk/guidance/cg65
Results Reference
background
PubMed Identifier
12575635
Citation
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.
Results Reference
background
PubMed Identifier
15728062
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.
Results Reference
background
Citation
NICE. Inadvertent perioperative hypothermia Overview. http://pathways.nice.org.uk/pathways/inadvertent-perioperative-hypothermia. 27.11.2017
Results Reference
background
PubMed Identifier
31560431
Citation
Guideline Quick View: Hypothermia. AORN J. 2019 Oct;110(4):463-465. doi: 10.1002/aorn.12843. No abstract available.
Results Reference
background
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Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
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