NCT00710320

Brief Summary

We aim that uncovering patients during induction of general anesthesia does not decrease core body temperature in pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

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

July 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

8 months

First QC Date

July 3, 2008

Last Update Submit

February 3, 2010

Conditions

Keywords

Children core temperature,Pediatric surgery,Anesthesia induction

Outcome Measures

Primary Outcomes (1)

  • Covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.

    1.5 years

Secondary Outcomes (1)

  • Covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group.

    1.5 years

Study Arms (1)

Cover and Uncover

Procedure/Surgery

Procedure: Covered and uncovered anesthesia induction

Interventions

We hypothesize that the core temperatures of: 1. the covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia. 2. both groups, covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group.

Also known as: Temperature, Pediatric, Urology, Anesthesia
Cover and Uncover

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children in an academic center

You may qualify if:

  • The ages of the subjects ranging from 6 months to 3 years undergoing surgery for circumcision or hernia repair with caudal block.

You may not qualify if:

  • ASA physical status classification greater than 2, unsigned or unattainable written informed consent form, induction of general anesthesia time of greater than 45 minutes, fever, or temperature regulation inability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Oklahoma Health Sciences Center Deparment of Anesthesiology

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

  • Bissonnette B. Temperature monitoring in pediatric anesthesia. Int Anesthesiol Clin. 1992 Summer;30(3):63-76.

    PMID: 1516974BACKGROUND
  • Hynson JM, Sessler DI, Moayeri A, McGuire J, Schroeder M. The effects of preinduction warming on temperature and blood pressure during propofol/nitrous oxide anesthesia. Anesthesiology. 1993 Aug;79(2):219-28, discussion 21A-22A. doi: 10.1097/00000542-199308000-00005.

    PMID: 8342834BACKGROUND

MeSH Terms

Conditions

Hypothermia

Interventions

TemperatureAnesthesia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment, ControlledEnvironment and Public HealthAnesthesia and Analgesia

Study Officials

  • Mohanad Shukry, MD

    The University of Oklahoma Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 4, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations