NCT00815191

Brief Summary

The primary objective of this study is to determine if the intraoperative distal esophageal (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in patients undergoing open colectomy under general anesthesia. This is a randomized study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable surgery

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

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 29, 2008

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

July 18, 2016

Completed
Last Updated

July 18, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

December 24, 2008

Results QC Date

February 27, 2016

Last Update Submit

June 7, 2016

Conditions

Surgery

Keywords

temperaturesurgeryheating device

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Distal Esophageal (Core) Temperature

    at 1 hour

Study Arms (2)

Vital Heat

ACTIVE COMPARATOR

Vital HEAT (vH2) Temperature Management System

Device: vital HEAT (vH2) Temperature Management System

Forced air

ACTIVE COMPARATOR

Forced-air warming

Device: a forced-air warming cover

Interventions

a forced-air warming coverDEVICE

A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery.

Forced air
vital HEAT (vH2) Temperature Management SystemDEVICE

The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery.

Vital Heat

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body-mass index 20-36 kg/m2;
  • Age 18-75 yrs;
  • ASA Physical Status 1-3.

You may not qualify if:

  • Patient requires an intravenous or arterial catheter distal to the elbow on both arms;
  • Serious skin lesions on the hands or arms;
  • History of serious vascular disease in the arms;
  • Pre-operative fever;
  • Contraindication to sevoflurane endotracheal anesthesia.
  • Pre-existing neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

Title
Daniel Sessler
Organization
Cleveland Clinic Foundation
DS@OR.org
216-444-4900

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Outcomes Research

Study Record Dates

First Submitted

December 24, 2008

First Posted

December 29, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 18, 2016

Results First Posted

July 18, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)