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Trial record 15 of 621 for:    oximeter

Validation of Next Generation Cerebral and Tissue Oximeter

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ClinicalTrials.gov Identifier: NCT03128372
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Oxygen Deficiency
Intervention Device: Desaturation
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desaturation
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Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.

Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.

Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title Desaturation
Hide Arm/Group Description

Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.

Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
31.4  (6.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
15
  46.9%
Male
17
  53.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  31.3%
White
19
  59.4%
More than one race
2
   6.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
 100.0%
1.Primary Outcome
Title Validated the Next Generation Oximeter
Hide Description Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance.
Time Frame Data collected from individual participant over 4 hour timeframe.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desaturation
Hide Arm/Group Description:

Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.

Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.

Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Percentage saturation
Cerebral Overall Mean Bias 1.22  (5.92)
Cerebral Overall Trending Mean Bias 0.83  (3.08)
Somatic Overall Trending Mean Bias 0.09  (1.73)
Time Frame 48 hours post study procedure (desaturation)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desaturation
Hide Arm/Group Description

Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.

Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.

All-Cause Mortality
Desaturation
Affected / at Risk (%)
Total   0/32 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Desaturation
Affected / at Risk (%) # Events
Total   0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Desaturation
Affected / at Risk (%) # Events
Total   2/32 (6.25%)    
Musculoskeletal and connective tissue disorders   
Clavicular pain  1  1/32 (3.13%)  1
Nervous system disorders   
Vasovagal episode  1  1/32 (3.13%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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: Julia Katilius
Organization: Medtronic
Phone: 1 303-305-2278
EMail: julia.z.katilius@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03128372     History of Changes
Other Study ID Numbers: MDT16010MAVJB3
First Submitted: April 5, 2017
First Posted: April 25, 2017
Results First Submitted: July 20, 2018
Results First Posted: November 9, 2018
Last Update Posted: November 9, 2018