HypothermiaPhase 4NCT02342431
Comparison of a Patient Warming System Using a Forced-air, Non-compressible Under-body Mattress Versus a Regular Forced-air Underbody Mattress System During Pediatric Cardiac Catheterization
A Phase 4 study testing Forced air warming compressible and Forced air non-compressible in people with Hypothermia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study is a comparison of a patient warming system using a forced-air, non-compressible under-body mattress (Möck \& Möck, Hamburg, Germany) versus a regular forced-air underbody mattress system during pediatric cardiac catheterization in 40 patients. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Hypothermia
- What is being tested?
- Forced air warming compressible and Forced air non-compressible
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Mar 2011
- Phase
- Phase 4
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patient scheduled for cardiac catheterization (diagnostic and/or interventional)< 1 year old
Who cannot join
- fever or therapeutic hypothermia
Trial locations and contacts
1 site in 1 country.
About this study
The study is a comparison of a patient warming system using a forced-air, non-compressible under-body mattress (Möck \& Möck, Hamburg, Germany) versus a regular forced-air underbody mattress system during pediatric cardiac catheterization in 40 patients.
The hypothesis is, that the non-compressible mattress provides better warming with less incidence of perioperative hypothermia (Core temperature < 36 °C) and faster warming slope (°C / time). The study is prospective, randomized, controlled and single-blinded.
Inclusion criteria will be pediatric patients < 1 year of age without fever or a treatment of therapeutic hypothermia.
- Conditions
- Hypothermia
- Being tested
- Forced air warming compressible, Forced air non-compressible
- Keywords
- Thermoregulation, Pediatric Anesthesia, Cardiac Catheterization
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced air warming compressibleDevice
Warming with a compressible forced air mattress
Forced air non-compressibleDevice
Warming with a non-compressible forced air mattress
| Study group | Role | What they receive |
|---|---|---|
| Forced air compressible warming | Active comparator | Warming with a compressible forced air mattress Receives: Device: Forced air warming compressible |
| Forced air non-compressible | Experimental | Warming with a non-compressible forced air mattress Receives: Device: Forced air non-compressible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypothermia
Measured: during surgery (1 - 6 hours)
Secondary outcomes (1)
Core Temperature Slope
Measured: during surgery (1 - 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startOct 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: Cardiac Catheterization no longer part of the anesthesia department A (no belonging to cardiac anesthesia, which is a different department)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Kimberger, Medical University of Vienna
- Investigators
- Oliver Kimberger, PD, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342431
- Sponsor's protocol ID
- momo_bh_1
- Status last verified
- Jan 2015
- First submitted
- 13 Nov 2012
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Patient Warming System Using a Forced-air, Non-compressible Under-body Mattress Versus a Regular Forced-air Underbody Mattress System During Pediatric Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT02342431
- Acronym / sponsor ID
- momo_bh_1
- Conditions
- Hypothermia
- Keywords
- Thermoregulation, Pediatric Anesthesia, Cardiac Catheterization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cardiac Catheterization no longer part of the anesthesia department A (no belonging to cardiac anesthesia, which is a different department)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 21 Jan 2015 (estimated)
- 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 study is a comparison of a patient warming system using a forced-air, non-compressible under-body mattress (Möck \& Möck, Hamburg, Germany) versus a regular forced-air underbody mattress system during pediatric cardiac catheterization in 40 patients.
The hypothesis is, that the non-compressible mattress provides better warming with less incidence of perioperative hypothermia (Core temperature < 36 °C) and faster warming slope (°C / time). The study is prospective, randomized, controlled and single-blinded.
Inclusion criteria will be pediatric patients < 1 year of age without fever or a treatment of therapeutic hypothermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forced air compressible warming | Active comparator | Device: Forced air warming compressibleWarming with a compressible forced air mattress |
| Forced air non-compressible | Experimental | Device: Forced air non-compressibleWarming with a non-compressible forced air mattress |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patient scheduled for cardiac catheterization (diagnostic and/or interventional)< 1 year old
Key exclusion criteria (1 listed)
- fever or therapeutic hypothermia
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 |
|---|---|---|
| Forced air warming compressibleWarming with a compressible forced air mattress | Device | Forced air compressible warming |
| Forced air non-compressibleWarming with a non-compressible forced air mattress | Device | Forced air non-compressible |
Primary outcome
Incidence of hypothermia
Time frame: during surgery (1 - 6 hours)
1 secondary outcome
Core Temperature Slope
Time frame: during surgery (1 - 6 hours)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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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.
Oliver Kimberger, PD, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Forced air warming compressible and Forced air non-compressible in people with Hypothermia, run by Medical University of Vienna at 1 site in Austria.
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 1 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: withdrawn, as of the sponsor's last update on 21 Jan 2015. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of hypothermia (time frame: during surgery (1 - 6 hours)). 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 21 Jan 2015.