Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00815191
First received: December 24, 2008
Last updated: June 7, 2016
Last verified: June 2016
Results First Received: February 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Surgery
Interventions: Device: a forced-air warming cover
Device: vital HEAT (vH2) Temperature Management System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Warm-water Sleeve

The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.

vital HEAT (vH2) Temperature Management System: 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.

Forced Air

Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.

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


Participant Flow:   Overall Study
    Warm-water Sleeve     Forced Air  
STARTED     38     35  
COMPLETED     37     34  
NOT COMPLETED     1     1  
Protocol Violation                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
5 patients with missing data, including 3 in the warm-water sleeve group and 2 in the forced air group.

Reporting Groups
  Description
Warm-water Sleeve

The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.

vital HEAT (vH2) Temperature Management System: 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.

Forced Air

Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.

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

Total Total of all reporting groups

Baseline Measures
    Warm-water Sleeve     Forced Air     Total  
Number of Participants  
[units: participants]
  37     34     71  
Age  
[units: years]
Mean (Standard Deviation)
  48  (15)     50  (15)     49  (15)  
Gender, Customized  
[units: participants]
     
Female     11     14     25  
Male     23     18     41  
Missing     3     2     5  
Race/Ethnicity, Customized  
[units: participants]
     
White     32     31     63  
African American     1     1     2  
Unknown     4     2     6  
Body mass index  
[units: kg/m^2]
Mean (Standard Deviation)
  26.1  (6.6)     26.3  (5.3)     26.2  (6.0)  



  Outcome Measures

1.  Primary:   Intraoperative Distal Esophageal (Core) Temperature   [ Time Frame: at 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Daniel Sessler
Organization: Cleveland Clinic Foundation
phone: 216-444-4900
e-mail: DS@OR.org



Responsible Party: d sessler, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00815191     History of Changes
Other Study ID Numbers: 07-1042
Study First Received: December 24, 2008
Results First Received: February 27, 2016
Last Updated: June 7, 2016
Health Authority: United States: Institutional Review Board