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Respiration Rate V2.0 in a Hospital Setting

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ClinicalTrials.gov Identifier: NCT01837537
Recruitment Status : Completed
First Posted : April 23, 2013
Results First Posted : February 3, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Respiratory Rate
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title no Treatment
Hide Arm/Group Description no treatment, prospective observational
Period Title: Overall Study
Started 90
Completed 90
Not Completed 0
Arm/Group Title no Treatment
Hide Arm/Group Description no treatment, prospective observational
Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 90 participants
54.2
(18 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
40
  44.4%
Male
50
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
American Indian or Alaska Native
2
   2.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
12
  13.3%
White
76
  84.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 90 participants
90
1.Primary Outcome
Title Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
Hide Description The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).
Time Frame up to 40 minutes of continuous monitoring
Hide Outcome Measure Data
Hide Analysis Population Description
90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)
Arm/Group Title no Treatment
Hide Arm/Group Description:
no treatment, prospective observational
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: BrPM (breaths per minute)
-0.82  (2.19)
2.Secondary Outcome
Title Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor
Hide Description The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.
Time Frame up to 40 minutes of continuous monitoring
Hide Outcome Measure Data
Hide Analysis Population Description
90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)
Arm/Group Title no Treatment
Hide Arm/Group Description:
no treatment, prospective observational
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: BrPM
-0.16  (2.85)
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   0/90 (0.00%) 
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   0/90 (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
Layout table for Results Point of Contact information
Name/Title: Michael Luna-Victoria
Organization: Medtronic
Phone: 303 305 2463
EMail: michael.luna-victoria@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01837537     History of Changes
Other Study ID Numbers: COVMOPR0399
First Submitted: April 17, 2013
First Posted: April 23, 2013
Results First Submitted: April 30, 2015
Results First Posted: February 3, 2017
Last Update Posted: July 17, 2017