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A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01094119
First received: March 25, 2010
Last updated: March 8, 2017
Last verified: March 2017
Results First Received: November 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Supportive Care
Condition: Warming Systems During Surgery
Interventions: Device: heated blanket
Device: heated pad

  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
Bair Hugger Heated Blanket

Patients will be warmed during surgery with the Bair Hugger heated blanket.

heated blanket: heated blanket

LMA PerfecTemp System

Patients will be warmed during surgery with the PerfecTemp heated pad .

heated pad: patients will be warmed with a heated pad during surgery.


Participant Flow:   Overall Study
    Bair Hugger Heated Blanket   LMA PerfecTemp System
STARTED   34   36 
COMPLETED   32   32 
NOT COMPLETED   2   4 
Lack of Efficacy                2                4 



  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.
Most baseline characteristics were well balanced be- tween the randomized groups. However, patients assigned to resistive heating were more likely to have higher ASA physical status classification. Thus, ASA status was adjusted for in all analyses. Patients in each warming group were given comparable doses of volatile anesthesia and opioid.

Reporting Groups
  Description
Bair Hugger Heated Blanket

Patients will be warmed during surgery with the Bair Hugger heated blanket.

heated blanket: heated blanket

LMA PerfecTemp System

Patients will be warmed during surgery with the PerfecTemp heated pad .

heated pad: patients will be warmed with a heated pad during surgery.

Total Total of all reporting groups

Baseline Measures
   Bair Hugger Heated Blanket   LMA PerfecTemp System   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   36   70 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (13)   51  (15)   51  (14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19  55.9%      24  66.7%      43  61.4% 
Male      15  44.1%      12  33.3%      27  38.6% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   34   34   68 
Not Caucasian   0   2   2 
Region of Enrollment 
[Units: Participants]
     
United States   23   23   46 
Canada   11   13   24 
preoperative oral temperature 
[Units: Degrees C]
Mean (Standard Deviation)
 36.2  (.9)   36.8  (.8)   36.2  (.8) 


  Outcome Measures
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1.  Primary:   Time Weighted Average Core Temperature   [ Time Frame: from tracheal intubation to 3 hours after or tracheal extubation ]

2.  Secondary:   Proportion of Patients With Temperatures Above 36 Degree   [ Time Frame: at the end of surgery ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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



Responsible Party: d sessler, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01094119     History of Changes
Other Study ID Numbers: 10-146
Study First Received: March 25, 2010
Results First Received: November 29, 2016
Last Updated: March 8, 2017