Temperature Study in Cesarean Section
Condition: Cesarean Section; Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

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 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).
    

Intervention name(s): Warmed fluids; Fluid warmer and warming blanket; Belmont fluid warmer; Bair hugger warming blanket
Intervention type(s): Other; Other; Device; Device
Intervention description(s): IV fluids warmed by a Belmont fluid warmer; Warm are blown into a Bair hugger warming blanket covering the patient; Belmont fluid warmer used to warm fluids; Bair hugger warming blanket laid on body
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention