Temperature Study in Cesarean Section

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01249014
First received: November 23, 2010
Last updated: November 24, 2010
Last verified: November 2010
  Purpose

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 Intervention
Cesarean Section
Device: warmed fluids
Device: Fluid warmer and warming blanket

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • temperature [ Time Frame: immediately prior to surgery upto 3hours post spinal anesthetic ] [ Designated as safety issue: No ]
    measured every 15 minutes from spinal anesthetic administration


Secondary Outcome Measures:
  • Fetal pH [ Time Frame: Post partum ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: November 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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 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).
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249014

Contacts
Contact: Pervez Sultan, MBChB, FRCA (650) 526-8414 p.sultan@doctors.org.uk

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Pervez Sultan, MBChB, FRCA    650-526-8414    p.sultan@doctors.org.uk   
Principal Investigator: Pervez Sultan         
Study Director: Edward Riley         
Sub-Investigator: Gill Hilton         
Sponsors and Collaborators
Stanford University
Investigators
Study Director: Edward Riley Stanford University
Sub-Investigator: Gill Hilton Stanford University
Principal Investigator: Pervez Sultan Stanford University
  More Information

No publications provided

Responsible Party: Pervez Sultan, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01249014     History of Changes
Other Study ID Numbers: SU-11102010-7189
Study First Received: November 23, 2010
Last Updated: November 24, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014