Temperature Study in Cesarean Section
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 6/10/2018 |
| Start Date: | November 1, 2013 |
| End Date: | April 30, 2015 |
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.
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).
- 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).
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).
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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