NCT01493700

Brief Summary

The purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

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

December 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

December 8, 2011

Last Update Submit

June 26, 2013

Conditions

Hypothermia

Keywords

heated circuitbody temperature

Outcome Measures

Primary Outcomes (1)

  • changes of body temperature

    record the changes of esophageal and peripheral body temperature every 15 minutes from base line during shouler arthroscopy

    every 15 minutes from base line

Study Arms (2)

control

EXPERIMENTAL

use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy

Procedure: heated circuit

electrically heated circuit

ACTIVE COMPARATOR

use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy

Procedure: control

Interventions

heated circuitPROCEDURE

use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy

Also known as: heat circuit
control
controlPROCEDURE

use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy

electrically heated circuit

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American society of anesthesiologist physical status 1 or 2
  • years old

You may not qualify if:

  • body mass index over 30 kg/m2
  • peripheral vascular disease
  • uncontrolled cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Cheon Lee

Incheon, South Korea

Location

Related Publications (1)

  • Lee HK, Jang YH, Choi KW, Lee JH. The effect of electrically heated humidifier on the body temperature and blood loss in spinal surgery under general anesthesia. Korean J Anesthesiol. 2011 Aug;61(2):112-6. doi: 10.4097/kjae.2011.61.2.112. Epub 2011 Aug 23.

    PMID: 21927679RESULT

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyung Cheon Lee, MD.PhD

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant professor

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 16, 2011

Study Start

December 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

KR(1)