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Evaluation of Respiratory Heast Loss as a Physiologic Patient Monitor for Acute Care Medicine

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ClinicalTrials.gov Identifier: NCT01808963
Recruitment Status : Completed
First Posted : March 12, 2013
Results First Posted : April 8, 2014
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Respiratory Heat Loss
Enrollment 13
Recruitment Details Recruitment from 12/19/12 through 5/31/13 in the UCDMC Peri-operative Suite.
Pre-assignment Details  
Arm/Group Title Study Group
Hide Arm/Group Description Patients undergoing elective surgery requiring endotracheal intubation for anesthesia.
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Study Group
Hide Arm/Group Description Respiratory Heat Loss Measured in Joules Per Minute
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  84.6%
>=65 years
2
  15.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
50  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
8
  61.5%
Male
5
  38.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine
Hide Description Respired gas heat content
Time Frame 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
Joules per minute
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Joules per minute
29.7  (15.6)
Time Frame 9 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group
Hide Arm/Group Description Respiratory Heat Loss Measured in Joules Per Minute
All-Cause Mortality
Study Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Group
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Group
Affected / at Risk (%)
Total   0/13 (0.00%) 
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: Dr. Neal Fleming
Organization: UC Davis Medical Center
Phone: 916-734-5394
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01808963     History of Changes
Other Study ID Numbers: 389048
First Submitted: March 7, 2013
First Posted: March 12, 2013
Results First Submitted: July 17, 2013
Results First Posted: April 8, 2014
Last Update Posted: May 30, 2017