HypothermiaNCT03429205
The Efficacy of External Warming During Laparoscopic Bariatric Surgery
A study testing No external heating used during surgery and External heating blanket used during surgery in people with Hypothermia and Morbid Obesity, run by Sheba Medical Center at 1 site in Israel.
Trial summary
External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypothermia, Morbid Obesity, Bariatric Surgery Candidate
- What is being tested?
- No external heating used during surgery and External heating blanket used during surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Mar 2018to 21 Nov 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for bariatric surgery
- Surgery time estimated to be < 2 hours
Who cannot join
- Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).
- Surgery time estimated to be more than 2 hours
Trial locations and contacts
1 site in 1 country.
About this study
External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump.
The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered.
The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last <2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.
- Conditions
- Hypothermia, Morbid Obesity, Bariatric Surgery Candidate
- Being tested
- No external heating used during surgery, External heating blanket used during surgery
- Keywords
- Sleeve gastrectomy, Roux-Y gastric bypass, Single anastomosis gastric bypass, Hypothermia, External heating blanket
- Medical subject headings
- Hypothermia, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No external heating used during surgeryOther
Deviation from external heating for all surgery standard
External heating blanket used during surgeryOther
Standard external heating plan used in all surgery types
| Study group | Role | What they receive |
|---|---|---|
| No heating - Study group | Experimental | Patient will undergo bariatric surgery without utilization of external heating device. Receives: Other: No external heating used during surgery |
| Heating - Control group | Other | Patient will undergo bariatric surgery with utilization of external heating device. Receives: Other: External heating blanket used during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative core-temperature decline
Core-temperature will be continuously measured throughout surgery
Measured: Surgery duration, up to 2 hours from surgery start-time
Arrival temperature at post anesthesia care unit (PACU)
Core temperature upon arrival to recovery room
Measured: arrival to recovery room, up to 2 h from surgery start-time
Secondary outcomes (3)
Hypothermia events
Measurement of core temperature <35 C
Measured: 3 hours from surgery start-time
Intraoperative blood loss
Intraoperative bleeding score will be used
Measured: Surgery duration, up to 2 hours from surgery start-time
Post operative complications
Complications after surgery (30 days), graded according to Clavien-Dindo classification
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Mar 2018
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Why it stopped: Recruiting pace too slow.
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 Sheba Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Goitein MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429205
- Sponsor's protocol ID
- 4578-17-SMC
- Status last verified
- Apr 2023
- First submitted
- 4 Feb 2018
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of External Warming During Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03429205
- Acronym / sponsor ID
- 4578-17-SMC
- Conditions
- Hypothermia, Morbid Obesity, Bariatric Surgery Candidate
- Keywords
- Sleeve gastrectomy, Roux-Y gastric bypass, Single anastomosis gastric bypass, Hypothermia, External heating blanket
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting pace too slow.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 12 Feb 2018 (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.
External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump.
The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered.
The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last <2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No heating - Study group | Experimental | Other: No external heating used during surgeryPatient will undergo bariatric surgery without utilization of external heating device. |
| Heating - Control group | Other | Other: External heating blanket used during surgeryPatient will undergo bariatric surgery with utilization of external heating device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for bariatric surgery
- Surgery time estimated to be < 2 hours
Key exclusion criteria (2 listed)
- Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).
- Surgery time estimated to be more than 2 hours
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 |
|---|---|---|
| No external heating used during surgeryDeviation from external heating for all surgery standard | Other | No heating - Study group |
| External heating blanket used during surgeryStandard external heating plan used in all surgery types | Other | Heating - Control group |
Primary outcome
Intraoperative core-temperature decline
Time frame: Surgery duration, up to 2 hours from surgery start-time
Core-temperature will be continuously measured throughout surgery
Arrival temperature at post anesthesia care unit (PACU)
Time frame: arrival to recovery room, up to 2 h from surgery start-time
Core temperature upon arrival to recovery room
3 secondary outcomes
Hypothermia events
Time frame: 3 hours from surgery start-time
Intraoperative blood loss
Time frame: Surgery duration, up to 2 hours from surgery start-time
Post operative complications
Time frame: 30 days postoperatively
Results and safety
The study was stopped early (reason given: Recruiting pace too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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.
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 No external heating used during surgery and External heating blanket used during surgery in people with Hypothermia and Morbid Obesity, run by Sheba Medical Center at 1 site in Israel.
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 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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 Israel. 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 was stopped early (reason given: Recruiting pace too slow.). Results are not available in the source record.
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?
Intraoperative core-temperature decline (time frame: Surgery duration, up to 2 hours from surgery start-time). The study lists 2 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 18 Apr 2023.