NCT01026766

Brief Summary

The aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypothermia in obese and non obese women under target controlled infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

Enrollment Period

1.7 years

First QC Date

December 3, 2009

Last Update Submit

December 3, 2009

Conditions

Hypothermia

Keywords

HypothermiaObesityHeat and moisture exchangerWarming blanketWarming fluidsGynecological surgeryIntravenous anesthesiaObese patientsNon obese patients

Study Arms (4)

Non obese/ Warming blankets

Non obese/ Warming intravenous fluids

Obese/ Warming intravenous fluids

Obese/ Warming blankets

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Forty female obese and non obese patients scheduled to gynecologic surgeries were warmed with warming blankets and warming intravenous fluids in association with heat and moisture exchanger.

You may qualify if:

  • women
  • years old
  • gynecologic
  • obesity

You may not qualify if:

  • fever
  • endocrine disease
  • hypertension
  • vasoactive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine of Botucatu

Botucatu, São Paulo, Brazil

Location

MeSH Terms

Conditions

HypothermiaObesity

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Luciano A Fernandes, MD

    Botucatu Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

March 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations

BR(1)