Temperature Change, BodyNCT03824262
The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position
A study testing HICO-VARIOTHERM 550 and Mistral-Air Plus forced air warming device in people with Temperature Change, Body, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- HICO-VARIOTHERM 550 and Mistral-Air Plus forced air warming device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2019to 4 May 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major abdominal surgery in litotomy position
- ASA I-II
- Anticipated operation time over 1 hour
Who cannot join
- Sepsis
- Hypothermia
- Hyperthermia
- Malignant Hyperthermia
- Tyroid dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University School of Medicine Hospital
Ankara, 06100
About this study
The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.
Read the detailed description
The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.
- Conditions
- Temperature Change, Body
- Being tested
- HICO-VARIOTHERM 550, Mistral-Air Plus forced air warming device
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HICO-VARIOTHERM 550Device
Warming during perioperative period.
Mistral-Air Plus forced air warming deviceDevice
Warming during perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device Receives: Device: HICO-VARIOTHERM 550; Device: Mistral-Air Plus forced air warming device |
| Group II | Active comparator | Mistral-Air Plus forced-air warming device Receives: Device: Mistral-Air Plus forced air warming device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature-esophageal probe
Esophageal probe used to measure core body temperature
Measured: Perioperative period-every 15 minutes
Secondary outcomes (6)
Body temperature-tympanic thermometer
Tympanic thermometer used to measure body temperature
Measured: Perioperative period-every 15 minutes
Body temperature-skin thermometer
Skin thermometer used to measure body temperature
Measured: Perioperative period-every 15 minutes
Duration of operation
Duration of operation compared with the change in body temperature
Measured: Perioperative period
Blood loss
Blood loss during the perioperative period
Measured: Perioperative period
Shivering after the operation
Assessment of shivering after operation in the recovery room with PAS score
Measured: Postoperative 1st hour every 10 minutes
Time to extubation
Time to extubation at the end of operation
Measured: The end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start4 Feb 2019
- Primary completion4 May 2019
- Study completion4 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Uzumcugil, Hacettepe University
- Investigators
- Meral Kanbak, Prof, Study chair, Hacettepe UniversityFİLİZ UZUMCUGIL, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824262
- Sponsor's protocol ID
- E.308215
- Status last verified
- May 2019
- First submitted
- 29 Jan 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position
- ClinicalTrials.gov ID
- NCT03824262
- Acronym / sponsor ID
- E.308215
- Conditions
- Temperature Change, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 4 May 2019 (actual)
- Study completion
- 4 May 2019 (actual)
- First posted
- 31 Jan 2019 (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.
The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.
Detailed description
The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: HICO-VARIOTHERM 550, Device: Mistral-Air Plus forced air warming deviceHICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device |
| Group II | Active comparator | Device: Mistral-Air Plus forced air warming deviceMistral-Air Plus forced-air warming device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major abdominal surgery in litotomy position
- ASA I-II
- Anticipated operation time over 1 hour
Key exclusion criteria (5 listed)
- Sepsis
- Hypothermia
- Hyperthermia
- Malignant Hyperthermia
- Tyroid dysfunction
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 |
|---|---|---|
| HICO-VARIOTHERM 550Warming during perioperative period. | Device | Group I |
| Mistral-Air Plus forced air warming deviceWarming during perioperative period. | Device | Group I, Group II |
Primary outcome
Body temperature-esophageal probe
Time frame: Perioperative period-every 15 minutes
Esophageal probe used to measure core body temperature
6 secondary outcomes
Body temperature-tympanic thermometer
Time frame: Perioperative period-every 15 minutes
Body temperature-skin thermometer
Time frame: Perioperative period-every 15 minutes
Duration of operation
Time frame: Perioperative period
Blood loss
Time frame: Perioperative period
Shivering after the operation
Time frame: Postoperative 1st hour every 10 minutes
Time to extubation
Time frame: The end of 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 7 May 2019.
- Individual participant dataSharing planned: No
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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.
Meral Kanbak, Prof study chair
Hacettepe University
FİLİZ UZUMCUGIL principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HICO-VARIOTHERM 550 and Mistral-Air Plus forced air warming device in people with Temperature Change, Body, run by Hacettepe University 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 5 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 7 May 2019. 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?
Body temperature-esophageal probe (time frame: Perioperative period-every 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2019.