NCT01249014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
2.9 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2015

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

November 23, 2010

Last Update Submit

June 6, 2018

Conditions

Cesarean SectionHypothermia

Outcome Measures

Primary Outcomes (1)

  • temperature

    measured every 15 minutes from spinal anesthetic administration

    immediately prior to surgery upto 3hours post spinal anesthetic

Secondary Outcomes (1)

  • Fetal pH

    Post partum

Study Arms (3)

Control

NO INTERVENTION

No peri-operative warming.

Warmed fluids

EXPERIMENTAL

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

Other: Warmed fluidsDevice: Belmont fluid warmer

Warmed fluids and warm air

EXPERIMENTAL

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

Other: Warmed fluidsOther: Fluid warmer and warming blanketDevice: Belmont fluid warmerDevice: Bair hugger warming blanket

Interventions

Warmed fluidsOTHER

IV fluids warmed by a Belmont fluid warmer

Warmed fluidsWarmed fluids and warm air
Fluid warmer and warming blanketOTHER

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

Warmed fluids and warm air
Belmont fluid warmerDEVICE

Belmont fluid warmer used to warm fluids

Warmed fluidsWarmed fluids and warm air
Bair hugger warming blanketDEVICE

Bair hugger warming blanket laid on body

Warmed fluids and warm air

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Riley

    Stanford University

    STUDY DIRECTOR

  • Gill Hilton

    Stanford University

    SUB INVESTIGATOR

  • Pervez Sultan

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 25, 2010

Study Start

November 1, 2013

Primary Completion

April 30, 2015

Study Completion

April 30, 2015

Last Updated

June 8, 2018

Record last verified: 2018-06

Locations

US(1)