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Completed

NCT Number: NCT01249014

Temperature Study in 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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warmed Fluids

Other

IV fluids warmed by a Belmont fluid warmer

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

Primary outcomes

  1. temperature

    Time frame: immediately prior to surgery upto 3hours post spinal anesthetic

    measured every 15 minutes from spinal anesthetic administration

Secondary outcomes

  1. Fetal pH

    Time frame: Post partum

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2010
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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