Cesarean SectionNCT01249014
Temperature Study in Cesarean Section
A study testing Warmed fluids, Fluid warmer and warming blanket and Belmont fluid warmer in people with Cesarean Section and Hypothermia, run by Stanford University at 1 site in United States.
Trial summary
During surgery body temperature can decrease which can adversely affect how people recover from surgery. This is a common problem. We aim to reduce the incidence of this drop in body temperature during surgery by testing the effectiveness of warm intravenous fluids that the patients will receive as they are being… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Hypothermia
- What is being tested?
- Warmed fluids, Fluid warmer and warming blanket and Belmont fluid warmer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2013to 30 Apr 2015
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:18-40 years. Healthy term (> 37 weeks) pregnant patients undergoing elective cesarean section with spinal anesthesia.
We will not discriminate with regard to ethnic background. ASA 1 and 2 patients scheduled for elective cesarean sections under spinal anesthesia at LPCH.
Exclusion Criteria:Not ASA 1 or 2 Not spinal anesthetic
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section
During surgery body temperature can decrease which can adversely affect how people recover from surgery. This is a common problem. We aim to reduce the incidence of this drop in body temperature during surgery by testing the effectiveness of warm intravenous fluids that the patients will receive as they are being infused, and of warm air blown into a blanket covering the body. The control group will not have any active warming methods.
Study group 1 will have the intravenous fluid warmer in the pre- and intraoperative period. Study group 2 will have a forced-air warmer in the intra-operative period as well as the fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital signs following delivery.
Read the detailed description
Potential participants will be approached by a member of the research team prior to surgery.
Patients will be fully informed of the study by a study investigator, full written informed consent will be obtained. We will recruit healthy ASA 1 and 2 patients undergoing uncomplicated elective cesarean sections. Patients will be randomised into one of three groups.
Control group will have no active warming. Study group 1 will have pre- and intraoperative intravenous fluid warming. Study group 2 will have the same as study group 1 but with additional intraoperative warming air blown into a blanket covering the body.
Temperature measurements will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery.
At the same time as temperature monitoring the patients will be assessed for shivering (4 point scale) and will be asked their comfort level with regard to their temperature (5 point scale).
We will record vital signs (measured routinely by the pediatricians at cesarean delivery) from the neonate immediately following delivery. Samples of blood will be taken from the placental cord following delivery to measure cord blood gas results.
We will carry out a chart review looking at the success rate of breast feeding (if applicable).
- We are studying the effect of intravenous fluid warming and forced-air warming on your body temperature at the time of your cesarean section.
- Perioperative hypothermia can have adverse affects on your health and recovery following surgery so the aim of this study is to find ways to prevent or reduce the incidence of hypothermia.
- Participants will be randomized into one of three groups. The control group will not receive any perioperative warming. Study group 1 will have intravenous fluids warmed. Study group 2 will be the same as group 1 with the addition of a forced-air warmer in the operating room. Your temperature will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery. At the time of the temperature measurements we will also assess any shivering you may have and also question you regarding how warm/cold you feel.
- Following delivery of the placenta we will send one blood sample taken from the placental cord to the biochemistry laboratory for analysis of the cord blood gases. The blood sample will not be stored for future studies.
- We will be observing the vital signs of the neonate immediately following delivery.
- We will be carrying out a chart review looking at the success rate of breast feeding (if applicable).
- Conditions
- Cesarean Section, Hypothermia
- Being tested
- Warmed fluids, Fluid warmer and warming blanket, Belmont fluid warmer, Bair hugger warming blanket
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmed fluidsOther
IV fluids warmed by a Belmont fluid warmer
Fluid warmer and warming blanketOther
Warm are blown into a Bair hugger warming blanket covering the patient
Belmont fluid warmerDevice
Belmont fluid warmer used to warm fluids
Bair hugger warming blanketDevice
Bair hugger warming blanket laid on body
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No peri-operative warming. |
| Warmed fluids | Experimental | Patients will receive warmed i.v. fluids administered pre- and intra-operatively. Receives: Other: Warmed fluids; Device: Belmont fluid warmer |
| Warmed fluids and warm air | Experimental | Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively. Receives: Other: Warmed fluids; Other: Fluid warmer and warming blanket; Device: Belmont fluid warmer; Device: Bair hugger warming blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature
measured every 15 minutes from spinal anesthetic administration
Measured: immediately prior to surgery upto 3hours post spinal anesthetic
Secondary outcomes (1)
Fetal pH
Measured: Post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study start1 Nov 2013
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Riley, Stanford University
- Investigators
- Edward Riley, Study director, Stanford UniversityGill Hilton, Sub-investigator, Stanford UniversityPervez Sultan, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249014
- Sponsor's protocol ID
- SU-11102010-7189
- Status last verified
- Jun 2018
- First submitted
- 23 Nov 2010
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT01249014
- Acronym / sponsor ID
- SU-11102010-7189
- Conditions
- Cesarean Section, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 25 Nov 2010 (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.
During surgery body temperature can decrease which can adversely affect how people recover from surgery. This is a common problem. We aim to reduce the incidence of this drop in body temperature during surgery by testing the effectiveness of warm intravenous fluids that the patients will receive as they are being infused, and of warm air blown into a blanket covering the body. The control group will not have any active warming methods.
Study group 1 will have the intravenous fluid warmer in the pre- and intraoperative period. Study group 2 will have a forced-air warmer in the intra-operative period as well as the fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital signs following delivery.
Detailed description
Potential participants will be approached by a member of the research team prior to surgery.
Patients will be fully informed of the study by a study investigator, full written informed consent will be obtained. We will recruit healthy ASA 1 and 2 patients undergoing uncomplicated elective cesarean sections. Patients will be randomised into one of three groups.
Control group will have no active warming. Study group 1 will have pre- and intraoperative intravenous fluid warming. Study group 2 will have the same as study group 1 but with additional intraoperative warming air blown into a blanket covering the body.
Temperature measurements will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery.
At the same time as temperature monitoring the patients will be assessed for shivering (4 point scale) and will be asked their comfort level with regard to their temperature (5 point scale).
We will record vital signs (measured routinely by the pediatricians at cesarean delivery) from the neonate immediately following delivery. Samples of blood will be taken from the placental cord following delivery to measure cord blood gas results.
We will carry out a chart review looking at the success rate of breast feeding (if applicable).
- We are studying the effect of intravenous fluid warming and forced-air warming on your body temperature at the time of your cesarean section.
- Perioperative hypothermia can have adverse affects on your health and recovery following surgery so the aim of this study is to find ways to prevent or reduce the incidence of hypothermia.
- Participants will be randomized into one of three groups. The control group will not receive any perioperative warming. Study group 1 will have intravenous fluids warmed. Study group 2 will be the same as group 1 with the addition of a forced-air warmer in the operating room. Your temperature will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery. At the time of the temperature measurements we will also assess any shivering you may have and also question you regarding how warm/cold you feel.
- Following delivery of the placenta we will send one blood sample taken from the placental cord to the biochemistry laboratory for analysis of the cord blood gases. The blood sample will not be stored for future studies.
- We will be observing the vital signs of the neonate immediately following delivery.
- We will be carrying out a chart review looking at the success rate of breast feeding (if applicable).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No peri-operative warming. |
| Warmed fluids | Experimental | Other: Warmed fluids, Device: Belmont fluid warmerPatients will receive warmed i.v. fluids administered pre- and intra-operatively. |
| Warmed fluids and warm air | Experimental | Other: Warmed fluids, Other: Fluid warmer and warming blanket, Device: Belmont fluid warmer, Device: Bair hugger warming blanketPatients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Warmed fluidsIV fluids warmed by a Belmont fluid warmer | Other | Warmed fluids, Warmed fluids and warm air |
| Fluid warmer and warming blanketWarm are blown into a Bair hugger warming blanket covering the patient | Other | Warmed fluids and warm air |
| Belmont fluid warmerBelmont fluid warmer used to warm fluids | Device | Warmed fluids, Warmed fluids and warm air |
| Bair hugger warming blanketBair hugger warming blanket laid on body | Device | Warmed fluids and warm air |
Primary outcome
temperature
Time frame: immediately prior to surgery upto 3hours post spinal anesthetic
measured every 15 minutes from spinal anesthetic administration
1 secondary outcome
Fetal pH
Time frame: Post partum
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 8 Jun 2018.
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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.
Edward Riley study director
Stanford University
Gill Hilton sub-investigator
Stanford University
Pervez Sultan principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warmed fluids, Fluid warmer and warming blanket and Belmont fluid warmer in people with Cesarean Section and Hypothermia, run by Stanford University 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?
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 8 Jun 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?
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?
temperature (time frame: immediately prior to surgery upto 3hours post spinal anesthetic). 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 8 Jun 2018.