Warming Systems During SurgeryNCT01094119
A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
A study testing heated blanket and heated pad in people with Warming Systems During Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Warming Systems During Surgery
- What is being tested?
- heated blanket and heated pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body-mass index 20-36 kg/m2
- Age 18-75 yrs
- ASA Physical Status 1-3
- Supine position (with or without lithotomy)
Who cannot join
- Pre-operative fever
- Serious skin lesions
- And contraindication to either PerfecTemp or forced-air warming
Trial locations and contacts
1 site in 1 country.
About this study
Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.
Secondary hypotheses include that:
- intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.
- Conditions
- Warming Systems During Surgery
- Being tested
- heated blanket, heated pad
- Keywords
- heated blanket, heated pad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heated blanketDevice
Also called Bair Hugger
heated blanket
heated padDevice
Also called LMA PerfecTemp system
patients will be warmed with a heated pad during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bair Hugger heated blanket | Active comparator | Patients will be warmed during surgery with the Bair Hugger heated blanket. Receives: Device: heated blanket |
| LMA PerfecTemp system | Active comparator | Patients will be warmed during surgery with the PerfecTemp heated pad . Receives: Device: heated pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Weighted Average Core Temperature
Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation
Measured: from tracheal intubation to 3 hours after or tracheal extubation
Secondary outcomes (1)
Proportion of Patients With Temperatures Above 36 Degree
Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery
Measured: at the 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 posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Warming Systems During SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d sessler, The Cleveland Clinic
- Investigators
- Daniel I Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094119
- Sponsor's protocol ID
- 10-146
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2010
- Last updated
- 19 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
- ClinicalTrials.gov ID
- NCT01094119
- Acronym / sponsor ID
- 10-146
- Conditions
- Warming Systems During Surgery
- Keywords
- heated blanket, heated pad
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Posted 19 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.
Secondary hypotheses include that:
- intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bair Hugger heated blanket | Active comparator | Device: heated blanketPatients will be warmed during surgery with the Bair Hugger heated blanket. |
| LMA PerfecTemp system | Active comparator | Device: heated padPatients will be warmed during surgery with the PerfecTemp heated pad . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body-mass index 20-36 kg/m2
- Age 18-75 yrs
- ASA Physical Status 1-3
- Supine position (with or without lithotomy)
Key exclusion criteria (3 listed)
- Pre-operative fever
- Serious skin lesions
- And contraindication to either PerfecTemp or forced-air warming
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 |
|---|---|---|
| heated blanketAlso: Bair Huggerheated blanket | Device | Bair Hugger heated blanket |
| heated padAlso: LMA PerfecTemp systempatients will be warmed with a heated pad during surgery. | Device | LMA PerfecTemp system |
Primary outcome
Time Weighted Average Core Temperature
Time frame: from tracheal intubation to 3 hours after or tracheal extubation
Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation
1 secondary outcome
Proportion of Patients With Temperatures Above 36 Degree
Time frame: at the end of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Daniel I Sessler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heated blanket and heated pad in people with Warming Systems During Surgery, run by The Cleveland Clinic at 1 site in United States.
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 4 inclusion and 3 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 19 Apr 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Weighted Average Core Temperature (time frame: from tracheal intubation to 3 hours after or tracheal extubation). 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 19 Apr 2017.