HypothermiaNCT00651898
Circulating-water Garment With Forced-air Warming and Circulating-water Mattress During Abdominal Surgery
An observational study of Hypothermia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see if the combination of a circulating water mattress beneath the patient combined with forced air warming over top of the patient will prevent hypothermia (low body temperature) just as well as a garment that circulates warm water around the patient, during your major abdominal… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypothermia
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jun 2008
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients between 18-85 years of age who are undergoing major abdominal surgery who do not have a contradiction to forced-air or circulating water warming. Patient's undergoing combined procedures are not eligible to participate. Patient can not have a core temperature over 38°C, be pregnant or
Who may be able to join
- MaJor abdominal surgery
- Age between 18 and 85 years.
Who cannot join
- Fever (core temperature >38°C)
- Combined procedures (e.g.: simultaneous liver and kidney transplantation)
- Contraindication to forced-air or circulating-water warming which would be impacted by use of warming blanket
- Anticipated veno-venous bypass
- Current Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Circulating-water Garment With a Combination of Forced-air Warming and Circulating-water Mattress Warming During Major Abdominal Surgery
The purpose of this study is to see if the combination of a circulating water mattress beneath the patient combined with forced air warming over top of the patient will prevent hypothermia (low body temperature) just as well as a garment that circulates warm water around the patient, during your major abdominal surgery. Patients will be randomly assigned to one of these two groups.
Read the detailed description
Group A: This group will receive the circulating water garment Group B: This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body
Once the patient is moved to the operating room table, the surface of the back will begin to be warmed using either the circulating-water garment for those in Group A or the circulating-water mattress for those in Group B. Following the start of anesthesia, additional warming will be done by covering the large parts of the legs and the upper and side of the chest using either the circulating-water garment for those in Group A or upper- and lower-body forced-air warmers for those in Group B.
Patient involvement will last until the warming devices are removed prior to departure from the operating room. There is no follow-up to this study.
- Conditions
- Hypothermia
- Keywords
- abdominal surgery, hypothermia, circulating water mattress
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | This group will receive the circulating water garment | |
| B | This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body connected to two warmers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature
Measured: Every 15 minutes throughout surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 50 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
- Maged Argalious, MD, Principal investigator, The Cleveland ClinicDaniel I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651898
- Sponsor's protocol ID
- 06-597
- Status last verified
- Feb 2016
- First submitted
- 31 Mar 2008
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Perez-Protto S, Sessler DI, Reynolds LF, Bakri MH, Mascha E, Cywinski J, Parker B, Argalious M. Circulating-water garment or the combination of a circulating-water mattress and forced-air cover to maintain core temperature during major upper-abdominal surgery. Br J Anaesth. 2010 Oct;105(4):466-70. doi: 10.1093/bja/aeq170. Epub 2010 Aug 3.
PubMed 20685683
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Circulating-water Garment With a Combination of Forced-air Warming and Circulating-water Mattress Warming During Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00651898
- Acronym / sponsor ID
- 06-597
- Conditions
- Hypothermia
- Keywords
- abdominal surgery, hypothermia, circulating water mattress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Apr 2008 (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 purpose of this study is to see if the combination of a circulating water mattress beneath the patient combined with forced air warming over top of the patient will prevent hypothermia (low body temperature) just as well as a garment that circulates warm water around the patient, during your major abdominal surgery. Patients will be randomly assigned to one of these two groups.
Detailed description
Group A: This group will receive the circulating water garment Group B: This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body
Once the patient is moved to the operating room table, the surface of the back will begin to be warmed using either the circulating-water garment for those in Group A or the circulating-water mattress for those in Group B. Following the start of anesthesia, additional warming will be done by covering the large parts of the legs and the upper and side of the chest using either the circulating-water garment for those in Group A or upper- and lower-body forced-air warmers for those in Group B.
Patient involvement will last until the warming devices are removed prior to departure from the operating room. There is no follow-up to this study.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –This group will receive the circulating water garment |
| B | – | –This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body connected to two warmers. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients between 18-85 years of age who are undergoing major abdominal surgery who do not have a contradiction to forced-air or circulating water warming. Patient's undergoing combined procedures are not eligible to participate. Patient can not have a core temperature over 38°C, be pregnant or
Key inclusion criteria (2 listed)
- MaJor abdominal surgery
- Age between 18 and 85 years.
Key exclusion criteria (5 listed)
- Fever (core temperature >38°C)
- Combined procedures (e.g.: simultaneous liver and kidney transplantation)
- Contraindication to forced-air or circulating-water warming which would be impacted by use of warming blanket
- Anticipated veno-venous bypass
- Current Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature
Time frame: Every 15 minutes throughout 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 1 Mar 2016.
- Derived from this study: PubMed 20685683Perez-Protto S, Sessler DI, Reynolds LF, Bakri MH, Mascha E, Cywinski J, Parker B, Argalious M. Circulating-water garment or the combination of a circulating-water mattress and forced-air cover to maintain core temperature during major upper-abdominal surgery. Br J Anaesth. 2010 Oct;105(4):466-70. doi: 10.1093/bja/aeq170. Epub 2010 Aug 3.
- Individual participant dataSharing planned: No
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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.
Maged Argalious, MD principal investigator
The Cleveland Clinic
Daniel I Sessler, MD study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, 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 2 inclusion and 5 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 1 Mar 2016. 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?
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?
The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature (time frame: Every 15 minutes throughout surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00651898, which also lists 1 linked publication.
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 1 Mar 2016.