HypothermiaNCT01722955
Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
A study testing Pre-warmed fluids and Room temperature fluids in people with Hypothermia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of the study is to compare effect of pre-warmed intravenous fluids on the early outcomes in ambulatory patients undergoing monitored anesthesia care. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Hypothermia
- What is being tested?
- Pre-warmed fluids and Room temperature fluids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Nov 2014
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20years to 70years old female patients undergoing urinary incontinence surgery under monitored anesthesia care.
Who cannot join
- Preoperative tympanic membrane temperature >38 or < 36
- End stage heart failure or renal failure
- Otitis media
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-warmed Intravenous Fluids on the Early Outcomes After Ambulatory Surgery Under Monitored Anesthesia Care
The aim of the study is to compare effect of pre-warmed intravenous fluids on the early outcomes in ambulatory patients undergoing monitored anesthesia care.
Read the detailed description
Monitored anesthesia care (MAC) has been increasing in fast track anesthesia for ambulatory or outpatient surgery. MAC provides lower anesthetic agents than general anesthesia, however it has been shown to result high anesthetic complication rate because of negligent monitoring. Therefore, aim of this study is to investigate the effect of pre-warmed intravenous fluids on the core body temperature and the early outcomes.
- Conditions
- Hypothermia
- Being tested
- Pre-warmed fluids, Room temperature fluids
- Keywords
- Prewarmed fluid, monitored anesthesia care, core body temperature, anesthetic satisfaction
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-warmed fluidsOther
Also called Warming intravenous (IV) fluid
IV fluid will be stored at 41℃ set hot cabinet for 8hours
Room temperature fluidsOther
Also called No warming intravenous fluids
Room temperature fluid will be stored at ambient temperature
| Study group | Role | What they receive |
|---|---|---|
| Pre-warmed fluids | Experimental | Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet. Receives: Other: Pre-warmed fluids |
| Room temperature fluids | Experimental | Room temperature fluids will be stored at ambient temperature. Receives: Other: Room temperature fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic membrane temperature
Preoperative dehydration will be supplemented with 10ml/kg of lactate Ringer's solution at the beginning of the anesthetic induction. 30 min after anesthetic induction is nearly after administering the fixed volume.
Measured: 30min after anesthetic induction
Secondary outcomes (1)
Postoperative chilling and shivering
Degree of chilling and shivering will be evaluated at the postanesthesia care unit after the surgery.
Measured: on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionNov 2014
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 Samsung 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Hee Kim, Samsung Medical Center
- Investigators
- Myung Hee Kim, MD,PhD, Principal investigator, Samsung MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722955
- Sponsor's protocol ID
- Prewarmed fluid
- Status last verified
- Nov 2014
- First submitted
- 4 Nov 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.
PubMed 19502035
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-warmed Intravenous Fluids on the Early Outcomes After Ambulatory Surgery Under Monitored Anesthesia Care
- ClinicalTrials.gov ID
- NCT01722955
- Acronym / sponsor ID
- Prewarmed fluid
- Conditions
- Hypothermia
- Keywords
- Prewarmed fluid, monitored anesthesia care, core body temperature, anesthetic satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Nov 2012 (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 study is to compare effect of pre-warmed intravenous fluids on the early outcomes in ambulatory patients undergoing monitored anesthesia care.
Detailed description
Monitored anesthesia care (MAC) has been increasing in fast track anesthesia for ambulatory or outpatient surgery. MAC provides lower anesthetic agents than general anesthesia, however it has been shown to result high anesthetic complication rate because of negligent monitoring. Therefore, aim of this study is to investigate the effect of pre-warmed intravenous fluids on the core body temperature and the early outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-warmed fluids | Experimental | Other: Pre-warmed fluidsPre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet. |
| Room temperature fluids | Experimental | Other: Room temperature fluidsRoom temperature fluids will be stored at ambient temperature. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20years to 70years old female patients undergoing urinary incontinence surgery under monitored anesthesia care.
Key exclusion criteria (3 listed)
- Preoperative tympanic membrane temperature >38 or < 36
- End stage heart failure or renal failure
- Otitis media
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 |
|---|---|---|
| Pre-warmed fluidsAlso: Warming intravenous (IV) fluidIV fluid will be stored at 41℃ set hot cabinet for 8hours | Other | Pre-warmed fluids |
| Room temperature fluidsAlso: No warming intravenous fluidsRoom temperature fluid will be stored at ambient temperature | Other | Room temperature fluids |
Primary outcome
Tympanic membrane temperature
Time frame: 30min after anesthetic induction
Preoperative dehydration will be supplemented with 10ml/kg of lactate Ringer's solution at the beginning of the anesthetic induction. 30 min after anesthetic induction is nearly after administering the fixed volume.
1 secondary outcome
Postoperative chilling and shivering
Time frame: on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)
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 19 Nov 2014.
- Results publication: PubMed 19502035Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.
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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.
Myung Hee Kim, MD,PhD principal investigator
Samsung MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-warmed fluids and Room temperature fluids in people with Hypothermia, run by Samsung Medical Center at 1 site in South Korea.
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 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 Nov 2014. 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 South Korea. 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?
Tympanic membrane temperature (time frame: 30min after anesthetic induction). 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 NCT01722955, 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 19 Nov 2014.