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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No peri-operative warming. | |
| Warmed fluids | Experimental | Patients will receive warmed i.v. fluids administered pre- and intra-operatively. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warmed fluids | Other | IV fluids warmed by a Belmont fluid warmer |
|
| Measure | Description | Time Frame |
|---|---|---|
| temperature | measured every 15 minutes from spinal anesthetic administration | immediately prior to surgery upto 3hours post spinal anesthetic |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal pH | Post partum |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Edward Riley | Stanford University | Study Director |
| Gill Hilton | Stanford University | Sub-Investigator |
| Pervez Sultan | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fluid warmer and warming blanket | Other | Warm are blown into a Bair hugger warming blanket covering the patient |
|
| Belmont fluid warmer | Device | Belmont fluid warmer used to warm fluids |
|
| Bair hugger warming blanket | Device | Bair hugger warming blanket laid on body |
|