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Respiration Rate V2.0 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01804062
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Focus of the Study is Measuring Respiratory Rate
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title no Treatment
Hide Arm/Group Description no treatment, prospective observational
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title no Treatment
Hide Arm/Group Description no treatment, prospective observational
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
32.9  (6.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
27
  90.0%
More than one race
1
   3.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
Hide Description The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.
Time Frame up to 40 minutes of continous monitoring
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Treatment
Hide Arm/Group Description:
no treatment, prospective observational
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: BrPM
-0.05  (1.04)
2.Secondary Outcome
Title ME +/- 1 Breath Per Minute, Max-N Sensor
Hide Description The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.
Time Frame up to 40 minutes of continuous monitoring
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Treatment
Hide Arm/Group Description:
no treatment, prospective observational
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: BrPM
-0.03  (1.05)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title no Treatment
Hide Arm/Group Description no treatment, prospective observational
All-Cause Mortality
no Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
no Treatment
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
no Treatment
Affected / at Risk (%)
Total   0/0 
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: Michael Luna-Victoria
Organization: Medtronic
Phone: 303 305 2463
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01804062     History of Changes
Other Study ID Numbers: COVMOPR0394
First Submitted: February 20, 2013
First Posted: March 5, 2013
Results First Submitted: July 14, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015