Temperature Study in Cesarean Section

NCT ID: NCT01249014

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-01
• Study Completion Date: 2015-04-30

Brief 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).

Conditions

Cesarean Section; Hypothermia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

No peri-operative warming.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Warmed fluids

Patients will receive warmed i.v. fluids administered pre- and intra-operatively.

Group Type: EXPERIMENTAL

Warmed fluids

Intervention Type: OTHER

IV fluids warmed by a Belmont fluid warmer

Belmont fluid warmer

Intervention Type: DEVICE

Belmont fluid warmer used to warm fluids

Warmed fluids and warm air

Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.

Group Type: EXPERIMENTAL

Warmed fluids

Intervention Type: OTHER

IV fluids warmed by a Belmont fluid warmer

Fluid warmer and warming blanket

Intervention Type: OTHER

Warm are blown into a Bair hugger warming blanket covering the patient

Belmont fluid warmer

Intervention Type: DEVICE

Belmont fluid warmer used to warm fluids

Bair hugger warming blanket

Intervention Type: DEVICE

Bair hugger warming blanket laid on body

Interventions

Warmed fluids

IV fluids warmed by a Belmont fluid warmer

Intervention Type: OTHER

Fluid warmer and warming blanket

Warm are blown into a Bair hugger warming blanket covering the patient

Intervention Type: OTHER

Belmont fluid warmer

Belmont fluid warmer used to warm fluids

Intervention Type: DEVICE

Bair hugger warming blanket

Bair hugger warming blanket laid on body

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

We will not discriminate with regard to ethnic background. ASA 1 and 2 patients scheduled for elective cesarean sections under spinal anesthesia at LPCH.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Edward Riley

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Riley

Role: STUDY_DIRECTOR

Stanford University

Gill Hilton

Role: SUB_INVESTIGATOR

Stanford University

Pervez Sultan

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-11102010-7189

Identifier Type: -

Identifier Source: org_study_id