Temperature Study in Cesarean Section
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|ClinicalTrials.gov Identifier: NCT01249014|
Recruitment Status : Unknown
Verified May 2015 by Edward Riley, Stanford University.
Recruitment status was: Recruiting
First Posted : November 25, 2010
Last Update Posted : May 20, 2015
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 two active body warming devices. One method is to warm the intravenous fluids that the patients will receive, as they are being infused. The other method is to use a forced-air warmer. This is a device that is similar to a blanket that the patient has laid over their upper body during the surgery which has warm air blown into it. 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.
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section Hypothermia||Device: warmed fluids Device: Fluid warmer and warming blanket||Not Applicable|
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 with the use of a forced-air warming device.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
No Intervention: control
no peri-operative warming
Active Comparator: warmed fluids
All IV fluids administered will be warmed by a belmont fluid warmer
Device: warmed fluids
use of IV fluid warmer to warm fluid administered to patient
Other Name: Belmont fluid warmer
Active Comparator: Fluid warmer and warming blanket
All fluids administered will be warmed by a belmont fluid warmer and a warming blanket (forced air warming device) will be used on these patients.
Device: Fluid warmer and warming blanket
patients will have IV fluids warmed through a belmont fluid warmer and warming blanket used (forced air will be warmed) a bair hugger device
Other Name: Belmont fluid warmer and warming blanket (Bair hugger)
- temperature [ Time Frame: immediately prior to surgery upto 3hours post spinal anesthetic ]measured every 15 minutes from spinal anesthetic administration
- Fetal pH [ Time Frame: Post partum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249014
|Contact: Pervez Sultan, MBChB, FRCA||(650) email@example.com|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Pervez Sultan, MBChB, FRCA 650-526-8414 firstname.lastname@example.org|
|Principal Investigator: Pervez Sultan|
|Study Director: Edward Riley|
|Sub-Investigator: Gill Hilton|
|Study Director:||Edward Riley||Stanford University|
|Sub-Investigator:||Gill Hilton||Stanford University|
|Principal Investigator:||Pervez Sultan||Stanford University|