AnesthesiaNCT06107647
Comparisons of Two Different Type Heater in Different Inhalation Anesthesia in Terms of Prevention of Hypothermia
A study testing COVIDIEN WarmTouch in people with Anesthesia and Hypothermia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Unintentional perioperative hypothermia is a common occurrence. One of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. It is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Hypothermia, Heat
- What is being tested?
- COVIDIEN WarmTouch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Mar 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-65, who are included in the ASA I-III group, who will undergo rhinoplasty.
Who cannot join
- Patients with BMI > 35 KG/M²
- Patients with body temperature >37.5°C, <36°C degrees
- Those with cardiovascular system or central nervous system disease
- Patients with thyroid disorders
- Patients with autonomic dysfunction
- Patients not between the ages of 18-65
Show all 9Show fewer
- Patients with missing information in the information form
- Patients using steroids or vasoactive drugs.
- Patients whose operation time is less than 30 minutes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Abdullah Pabucci
Istanbul
abdullah md pabucci, +905531918241, dr.pabucci@gmail.com
arzu md yıldırım ar, +905053822729, dr.arzuyildirim@hotmail.com
About this study
Official title: Prospective Comparisons of Active Air Blow Heaters and Resistive Type Heaters in High-current and Low-current Inhalation Anesthesia in Terms of the Prevention of Hypothermia
Unintentional perioperative hypothermia is a common occurrence. One of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. It is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. In this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia
Read the detailed description
ABSTRACT
PROSPECTIVE COMPARISON OF ACTIVE AIR BLOWN HEATER AND RESISTIVE TYPE HEATERS FOR PREVENTION OF HYPOTHERMIA IN HIGH CURRENT AND LOW CURRENT INHALATION ANESTHESIA
Aim: Unintentional perioperative hypothermia is a common occurrence. One of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. It is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. In this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia.
Materials and Methods: After ethics committee approval (Date: 08.12.2022/23), 112 patients with American Society of Anesthesiologist (ASA; American Society of Anesthesiologists) I-III, who were to undergo rhinoplasty between June 01, 2023 and January 01, 2024, were included in the study after informed consent was obtained. Group DA was defined as low flow anesthesia and active air blast heater, group DR as low flow anesthesia and resistive heater, group YA as high flow anesthesia and active air blast heater, and group YR as high flow anesthesia and resistive heater. Each group consisted of 28 patients. Heart rate, systolic, diastolic and mean arterial pressure, peripheral oxygen saturation values and body temperature values were measured and recorded at certain time intervals during the perioperative period and in the recovery unit. Body temperatures were also recorded in the ward. Thermal comfort scores were evaluated on admission, in the recovery unit and in the ward, while shivering score and patient satisfaction score were evaluated only in the recovery unit.
- Conditions
- Anesthesia, Hypothermia, Heat
- Being tested
- COVIDIEN WarmTouch
- Keywords
- High flow, hypothermia, low flow, rhinoplasty
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVIDIEN WarmTouchDevice
Also called INDITHERM Medical Alpha
"COVIDIEN WarmTouch will be used as an active air blowing heater. Patients will be warmed starting from the beginning of anesthesia."
"The INDITHERM Medical Alpha, which is a resistive heater, will be applied to patients starting at the beginning of anesthesia."
| Study group | Role | What they receive |
|---|---|---|
| GRUP DA | Experimental | Patients who will be given low-flow anesthesia during the operation and will be heated with an active air blower heater. Receives: Device: COVIDIEN WarmTouch |
| GRUP YA | Experimental | Patients who will be given high current anesthesia during the operation and will be heated with an active air blower heater. Receives: Device: COVIDIEN WarmTouch |
| GRUP DR | Experimental | Patients who will be given low-flow anesthesia during the operation and will be heated with a resistive heater Receives: Device: COVIDIEN WarmTouch |
| GRUP YR | Experimental | Patients who will be treated with high-flow anesthesia and heated with a resistive heater during the operation Receives: Device: COVIDIEN WarmTouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of body temperatures in patients using two different body heaters during anesthesia applications.
In our study, two patient groups receiving high current and low current anesthesia will be heated with only one type of heater, either active air blowing heater or resistive heater, from the beginning of anesthesia. Their body temperatures will be measured and recorded throughout the operation.
In our study, COVIDIEN WarmTouch will be used as an active air blowing heater. INDITHERM Medical Alpha will be used as a resistive-type heater. Throughout the entire operation, body temperature will be monitored using the zero-heat flow method from the temporal artery to the body surface (3M Spot ON).
Measured: 6 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jun 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Pabucci, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- abdullah pabucci, Principal investigator, fatih sultan mehmet research and traning hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107647
- Sponsor's protocol ID
- ABDULLAHPABUCCI1
- Status last verified
- Oct 2023
- First submitted
- 17 Aug 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparisons of Active Air Blow Heaters and Resistive Type Heaters in High-current and Low-current Inhalation Anesthesia in Terms of the Prevention of Hypothermia
- ClinicalTrials.gov ID
- NCT06107647
- Acronym / sponsor ID
- ABDULLAHPABUCCI1
- Conditions
- Anesthesia, Hypothermia, Heat
- Keywords
- High flow, hypothermia, low flow, rhinoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 30 Oct 2023 (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.
Unintentional perioperative hypothermia is a common occurrence. One of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. It is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. In this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia
Detailed description
ABSTRACT
PROSPECTIVE COMPARISON OF ACTIVE AIR BLOWN HEATER AND RESISTIVE TYPE HEATERS FOR PREVENTION OF HYPOTHERMIA IN HIGH CURRENT AND LOW CURRENT INHALATION ANESTHESIA
Aim: Unintentional perioperative hypothermia is a common occurrence. One of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. It is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. In this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia.
Materials and Methods: After ethics committee approval (Date: 08.12.2022/23), 112 patients with American Society of Anesthesiologist (ASA; American Society of Anesthesiologists) I-III, who were to undergo rhinoplasty between June 01, 2023 and January 01, 2024, were included in the study after informed consent was obtained. Group DA was defined as low flow anesthesia and active air blast heater, group DR as low flow anesthesia and resistive heater, group YA as high flow anesthesia and active air blast heater, and group YR as high flow anesthesia and resistive heater. Each group consisted of 28 patients. Heart rate, systolic, diastolic and mean arterial pressure, peripheral oxygen saturation values and body temperature values were measured and recorded at certain time intervals during the perioperative period and in the recovery unit. Body temperatures were also recorded in the ward. Thermal comfort scores were evaluated on admission, in the recovery unit and in the ward, while shivering score and patient satisfaction score were evaluated only in the recovery unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GRUP DA | Experimental | Device: COVIDIEN WarmTouchPatients who will be given low-flow anesthesia during the operation and will be heated with an active air blower heater. |
| GRUP YA | Experimental | Device: COVIDIEN WarmTouchPatients who will be given high current anesthesia during the operation and will be heated with an active air blower heater. |
| GRUP DR | Experimental | Device: COVIDIEN WarmTouchPatients who will be given low-flow anesthesia during the operation and will be heated with a resistive heater |
| GRUP YR | Experimental | Device: COVIDIEN WarmTouchPatients who will be treated with high-flow anesthesia and heated with a resistive heater during the operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18-65, who are included in the ASA I-III group, who will undergo rhinoplasty.
Key exclusion criteria (9 listed)
- Patients with BMI > 35 KG/M²
- Patients with body temperature >37.5°C, <36°C degrees
- Those with cardiovascular system or central nervous system disease
- Patients with thyroid disorders
- Patients with autonomic 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 |
|---|---|---|
| COVIDIEN WarmTouchAlso: INDITHERM Medical Alpha"COVIDIEN WarmTouch will be used as an active air blowing heater. Patients will be warmed starting from the beginning of anesthesia." "The INDITHERM Medical Alpha, which is a resistive heater, will be applied to patients starting at the beginning of anesthesia." | Device | GRUP DA, GRUP DR, GRUP YA, GRUP YR |
Primary outcome
Measurement of body temperatures in patients using two different body heaters during anesthesia applications.
Time frame: 6 mounth
In our study, two patient groups receiving high current and low current anesthesia will be heated with only one type of heater, either active air blowing heater or resistive heater, from the beginning of anesthesia. Their body temperatures will be measured and recorded throughout the operation. In our study, COVIDIEN WarmTouch will be used as an active air blowing heater. INDITHERM Medical Alpha will be used as a resistive-type heater. Throughout the entire operation, body temperature will be monitored using the zero-heat flow method from the temporal artery to the body surface (3M Spot ON).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
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.
abdullah pabucci principal investigator
fatih sultan mehmet research and traning hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVIDIEN WarmTouch in people with Anesthesia and Hypothermia, run by Fatih Sultan Mehmet Training and Research Hospital 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdullah md pabucci (+905531918241, dr.pabucci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of body temperatures in patients using two different body heaters during anesthesia applications. (time frame: 6 mounth). 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 31 Oct 2023.