HypothermiaNCT01026766
Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia
An observational study of Hypothermia, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypothermia in obese and non obese women under target controlled infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypothermia
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Nov 2009
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Forty female obese and non obese patients scheduled to gynecologic surgeries were warmed with warming blankets and warming intravenous fluids in association with heat and moisture exchanger.
Who may be able to join
- women
- 18-65 years old
- gynecologic
- obesity
Who cannot join
- fever
- endocrine disease
- hypertension
- vasoactive drugs
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypothermia in obese and non obese women under target controlled infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.
- Conditions
- Hypothermia
- Keywords
- Hypothermia, Obesity, Heat and moisture exchanger, Warming blanket, Warming fluids, Gynecological surgery, Intravenous anesthesia, Obese patients, Non obese patients
- Medical subject headings
- Hypothermia, Obesity
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 |
|---|---|---|
| Non obese/ Warming blankets | Not described | |
| Non obese/ Warming intravenous fluids | Not described | |
| Obese/ Warming intravenous fluids | Not described | |
| Obese/ Warming blankets | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionNov 2009
- Study completionNov 2009
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Luciano A Fernandes, MD, Principal investigator, Botucatu Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026766
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-32
- Status last verified
- Dec 2009
- First submitted
- 3 Dec 2009
- Last updated
- 4 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT01026766
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-32
- Conditions
- Hypothermia
- Keywords
- Hypothermia, Obesity, Heat and moisture exchanger, Warming blanket, Warming fluids, Gynecological surgery, Intravenous anesthesia, Obese patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Dec 2009 (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 aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypothermia in obese and non obese women under target controlled infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non obese/ Warming blankets | – | – |
| Non obese/ Warming intravenous fluids | – | – |
| Obese/ Warming intravenous fluids | – | – |
| Obese/ Warming blankets | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Forty female obese and non obese patients scheduled to gynecologic surgeries were warmed with warming blankets and warming intravenous fluids in association with heat and moisture exchanger.
Key inclusion criteria (4 listed)
- women
- 18-65 years old
- gynecologic
- obesity
Key exclusion criteria (4 listed)
- fever
- endocrine disease
- hypertension
- vasoactive drugs
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
Not reported in the source record.
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 4 Dec 2009.
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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.
Luciano A Fernandes, MD principal investigator
Botucatu Medical School
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 UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 4 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 4 Dec 2009. 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 Brazil. 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.
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 4 Dec 2009.