Temperature Measurement in Post-Anesthesia Care Units | NCT00614588

Studies
Temperature Measurement in Post-Anesthesia Care Units

NCT00614588

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Jul 20, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Surgery
Postoperative
Laparoscopic Surgery
General Anesthesia

Interventions

Body temperature thermometers

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jan 31, 2008

First Submission Date that Met QC Criteria

Jan 31, 2008

First Posted Date

Feb 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2016

Last Update Posted Date

Jul 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the accuracy of several thermometers and temperature changes during surgery and immediately after surgery.

Detailed Description

Several measurements of temperature will be taken at 30 minute intervals during surgery under general anesthesia and in the post operative care unit. Measurements will be taken as follows:

esophagus using an internal stethoscope
urinary bladder using a catheter
ear canal
skin of the forehead using adhesive devices(4 thermometers)
axilla ("armpit") using adhesive devices(2 thermometers)
mouth
skin of the upper chest

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
observation group		Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.	Device: Body temperature thermometers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Body temperature thermometers	Device	Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use.		Discharge from Post Anesthesia Care Unit

Secondary Outcomes

Measure	Description	Time Frame
To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit.		PostAnesthesia Care Unit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 80 years of age
American Society of Anesthesiologists (ASA) physical status of 1-3
laparoscopic surgery of the abdomen or pelvis that is expected to require general endotracheal anesthesia and insertion of a Foley catheter expected to be in place for at least one hour after surgery

Exclusion Criteria:

under 18 or over 80 years of age
pre-existing nasogastric tube
require bispectral index monitoring
upper esophageal disease
forehead rash or infection, oral infection or trauma, or ear infection or drainage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel I Sessler, MD	The Cleveland Clinic	Study Chair
Daniel I Sessler, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States