HypothermiaNCT01649596
Impact of Expanded Peri Operative Warming
A study testing Warming Gown in people with Hypothermia and Complications, run by Ascension Health at 1 site in United States.
Trial summary
The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Complications
- What is being tested?
- Warming Gown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are adult patients 18 years and older elective surgery of > 1 hour
Who cannot join
- Emergency and/or trauma cases
- Patients with diminished mental capacity unable to fill out or respond to survey questions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
Official title: Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery
The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.
Read the detailed description
This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups.
This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.
- Conditions
- Hypothermia, Complications
- Being tested
- Warming Gown, Standard of care warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warming GownDevice
Also called 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer
Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.
Standard of care warmingOther
The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery.
| Study group | Role | What they receive |
|---|---|---|
| Warming Gown | Active comparator | Comparison of two types of warming processes prior to, during, and after the surgery procedure. Receives: Device: Warming Gown |
| Standard of Care Warming | Other | Standard of care warming with hospital-issued blankets. Receives: Other: Standard of care warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypothermic Events
The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).
Measured: 12 hours
Secondary outcomes (1)
Patient Satisfaction
Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat \& highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
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 HypothermiaStudies 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
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Principal investigator, Tarik Wasfie, MD, Ascension Health
- Investigators
- Tarik Wasfie, MD, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649596
- Sponsor's protocol ID
- GRMC120009
- Status last verified
- Apr 2018
- First submitted
- 23 Jul 2012
- Last updated
- 5 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual data was de-identified and not available to share on an individual level. Aggregate data was planned to shared by publishing in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT01649596
- Acronym / sponsor ID
- GRMC120009
- Conditions
- Hypothermia, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Posted 5 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.
Detailed description
This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups.
This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warming Gown | Active comparator | Device: Warming GownComparison of two types of warming processes prior to, during, and after the surgery procedure. |
| Standard of Care Warming | Other | Other: Standard of care warmingStandard of care warming with hospital-issued blankets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects are adult patients 18 years and older elective surgery of > 1 hour
Key exclusion criteria (2 listed)
- Emergency and/or trauma cases
- Patients with diminished mental capacity unable to fill out or respond to survey questions.
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 |
|---|---|---|
| Warming GownAlso: 3M Bair Paws Flex Gown and Bair Paws Model 875 WarmerForced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery. | Device | Warming Gown |
| Standard of care warmingThe intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery. | Other | Standard of Care Warming |
Primary outcome
Incidence of Hypothermic Events
Time frame: 12 hours
The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).
1 secondary outcome
Patient Satisfaction
Time frame: 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual data was de-identified and not available to share on an individual level. Aggregate data was planned to shared by publishing in a scientific journal.
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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.
Tarik Wasfie, MD principal investigator
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warming Gown in people with Hypothermia and Complications, run by Ascension Health 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 1 inclusion and 2 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 5 Apr 2018. 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 5 Apr 2018). 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?
Incidence of Hypothermic Events (time frame: 12 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 5 Apr 2018.