Hypothermia; AnesthesiaNCT04996407
Survival Thermal Blanket Versus Draping Fabric to Prevent Hypothermia in Geriatric Surgical Patients
A study testing survival thermal blanket and draping fabric in people with Hypothermia; Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia; Anesthesia
- What is being tested?
- survival thermal blanket and draping fabric
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Mar 2021to 30 Apr 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 60 years old
- Physical status ASA 1-3
- Undergo elective surgery under general anesthesia with or without regional anesthesia
Who cannot join
- Thermoregulation disturbance
- Abnormal thyroid function
- Fever caused by infectious disease in 7 days prior to surgery
- Pre-induction hypothermia with temperature below 36 degree
- On routine antipiretic
- Unstable hemodynamic preoperative and intraoperative
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Comparison Effect of Using Between Survival Thermal Blanket and Draping Fabric as Substitute for Perforated Blanket With Forced Air Warmer Usage as Perioperative Warmer : Study on Inadvertent Perioperative Hypotermia in Geratric Patients
This study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.
Read the detailed description
Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.
- Conditions
- Hypothermia; Anesthesia
- Being tested
- survival thermal blanket, draping fabric
- Keywords
- perioperative hypothermia, geriatric, survival thermal blanket, draping fabric
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survival thermal blanketDevice
patients were given a thermal blanket
draping fabricDevice
Patients were given a draping fabric
| Study group | Role | What they receive |
|---|---|---|
| survival thermal blanket | Active comparator | Patient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia Receives: Device: survival thermal blanket; Device: draping fabric |
| draping fabric | Active comparator | Patient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia Receives: Device: survival thermal blanket; Device: draping fabric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with hypothermia in survival thermal blanket group
Measure by nasopharyngeal thermometer
Measured: Before induction
Number of participants with hypothermia in survival thermal blanket group
Measure by nasopharyngeal thermometer
Measured: every 15 minute during anesthesia
Number of participants with hypothermia in survival thermal blanket group
Measure by nasopharyngeal thermometer
Measured: end of surgery
Secondary outcomes (3)
Number of participants with hypothermia in draping fabric group
Measure by nasopharyngeal thermometer
Measured: Before induction
Number of participants with hypothermia in draping fabric group
Measure by nasopharyngeal thermometer
Measured: every 15 minute during anesthesia
Number of participants with hypothermia in draping fabric group
Measure by nasopharyngeal thermometer
Measured: end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start5 Mar 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996407
- Sponsor's protocol ID
- IndonesiaUAnes108
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Effect of Using Between Survival Thermal Blanket and Draping Fabric as Substitute for Perforated Blanket With Forced Air Warmer Usage as Perioperative Warmer : Study on Inadvertent Perioperative Hypotermia in Geratric Patients
- ClinicalTrials.gov ID
- NCT04996407
- Acronym / sponsor ID
- IndonesiaUAnes108
- Conditions
- Hypothermia; Anesthesia
- Keywords
- perioperative hypothermia, geriatric, survival thermal blanket, draping fabric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 9 Aug 2021 (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 compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.
Detailed description
Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survival thermal blanket | Active comparator | Device: survival thermal blanket, Device: draping fabricPatient will be using survival thermal blanket as substitute for perforated blanket with forced air warmer during anesthesia |
| draping fabric | Active comparator | Device: survival thermal blanket, Device: draping fabricPatient will be using draping fabrics as substitute for perforated blanket with forced air warmer during anesthesia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 60 years old
- Physical status ASA 1-3
- Undergo elective surgery under general anesthesia with or without regional anesthesia
Key exclusion criteria (6 listed)
- Thermoregulation disturbance
- Abnormal thyroid function
- Fever caused by infectious disease in 7 days prior to surgery
- Pre-induction hypothermia with temperature below 36 degree
- On routine antipiretic
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 |
|---|---|---|
| survival thermal blanketpatients were given a thermal blanket | Device | draping fabric, survival thermal blanket |
| draping fabricPatients were given a draping fabric | Device | draping fabric, survival thermal blanket |
Primary outcome
Number of participants with hypothermia in survival thermal blanket group
Time frame: Before induction
Measure by nasopharyngeal thermometer
Number of participants with hypothermia in survival thermal blanket group
Time frame: every 15 minute during anesthesia
Measure by nasopharyngeal thermometer
Number of participants with hypothermia in survival thermal blanket group
Time frame: end of surgery
Measure by nasopharyngeal thermometer
3 secondary outcomes
Number of participants with hypothermia in draping fabric group
Time frame: Before induction
Number of participants with hypothermia in draping fabric group
Time frame: every 15 minute during anesthesia
Number of participants with hypothermia in draping fabric group
Time frame: end of surgery
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 9 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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 survival thermal blanket and draping fabric in people with Hypothermia; Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
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 6 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 9 Aug 2021. 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 Indonesia. 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?
Number of participants with hypothermia in survival thermal blanket group (time frame: Before induction). The study lists 3 primary outcomes in all. 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 9 Aug 2021.