HypothermiaNCT05302323
Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
A study testing Disposable Drape and Reusable Drape in people with Hypothermia, run by Neslihan Ilkaz at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- Disposable Drape and Reusable Drape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2-3
- Patients with abdominal surgery
- Patients receiving general anesthesia
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane training and research hospital
Ankara, Keçiören, 06010
About this study
This study was planned to investigate whether the wetness of surgical drapes (disposable and resusable drapes) used in the intraoperative period causes hypothermia.
Read the 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.
- Conditions
- Hypothermia
- Being tested
- Disposable Drape, Reusable Drape
- Keywords
- Hypothermia, perioperative nursing, operating room nursing, unintended hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable DrapeOther
Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery
Reusable DrapeOther
Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery
| Study group | Role | What they receive |
|---|---|---|
| Disposable Drapes | Other | group using disposable surgical drapes Receives: Other: Disposable Drape |
| Reusable Drapes | Other | group using reusable surgical drapes Receives: Other: Reusable Drape |
What is being measured
The primary outcome is the main question the study is designed to answer.
tympanic and esophageal body temperature measurement between two groups
Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.
Measured: throughout the operation (min.2 hours) (max. 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Apr 2019
- Primary completion30 Nov 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- major abdominal surgery
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neslihan Ilkaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neslihan Ilkaz, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302323
- Sponsor's protocol ID
- Interventional
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19853810Hooper 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.
PubMed 21126665Bashaw MA. Guideline Implementation: Preventing Hypothermia. AORN J. 2016 Mar;103(3):305-10; quiz 311-3. doi: 10.1016/j.aorn.2016.01.009.
PubMed 26924369NICE. Hypothermia: prevention and management in adults having surgery. Clinical guideline Published: 23 April 2008, Last Updated 2016, nice.org.uk/guidance/cg65
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.
PubMed 12575635Maglinger 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.
PubMed 15728062NICE. Inadvertent perioperative hypothermia Overview. http://pathways.nice.org.uk/pathways/inadvertent-perioperative-hypothermia. 27.11.2017
Guideline Quick View: Hypothermia. AORN J. 2019 Oct;110(4):463-465. doi: 10.1002/aorn.12843. No abstract available.
PubMed 31560431
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia
- ClinicalTrials.gov ID
- NCT05302323
- Acronym / sponsor ID
- Interventional
- Conditions
- Hypothermia
- Keywords
- Hypothermia, perioperative nursing, operating room nursing, unintended hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Neslihan IlkazUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- major abdominal surgery
| Arm | Type | Receives |
|---|---|---|
| Disposable Drapes | Other | Other: Disposable Drapegroup using disposable surgical drapes |
| Reusable Drapes | Other | Other: Reusable Drapegroup using reusable surgical drapes |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-2-3
- Patients with abdominal surgery
- Patients receiving general anesthesia
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposable DrapeDisposable surgical drapes, consisting of 6 pieces, were used as a set during surgery | Other | Disposable Drapes |
| Reusable DrapeReusable surgical drapes, consisting of 6 pieces, were used as a set during surgery | Other | Reusable Drapes |
Primary outcome
tympanic and esophageal body temperature measurement between two groups
Time frame: throughout the operation (min.2 hours) (max. 6 hours)
Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Background: PubMed 19853810Hooper 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.
- Background: PubMed 21126665Hooper 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.
- Background: PubMed 26924369Bashaw MA. Guideline Implementation: Preventing Hypothermia. AORN J. 2016 Mar;103(3):305-10; quiz 311-3. doi: 10.1016/j.aorn.2016.01.009.
- BackgroundNICE. Hypothermia: prevention and management in adults having surgery. Clinical guideline Published: 23 April 2008, Last Updated 2016, nice.org.uk/guidance/cg65
- Background: PubMed 12575635Association 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.
- Background: PubMed 15728062Maglinger 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.
- BackgroundNICE. Inadvertent perioperative hypothermia Overview. http://pathways.nice.org.uk/pathways/inadvertent-perioperative-hypothermia. 27.11.2017
- Background: PubMed 31560431Guideline Quick View: Hypothermia. AORN J. 2019 Oct;110(4):463-465. doi: 10.1002/aorn.12843. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable Drape and Reusable Drape in people with Hypothermia, run by Neslihan Ilkaz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tympanic and esophageal body temperature measurement between two groups (time frame: throughout the operation (min.2 hours) (max. 6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302323, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.