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Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion

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ClinicalTrials.gov Identifier: NCT02247765
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Healthy
Hypoxia
Interventions Device: Arterial line
Device: Motion
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title USB Pulse Oximetry Monitor Interface Cable
Hide Arm/Group Description

Additional interventions include the following: Radial Arterial Line placement involves introduction of a standard arterial catheter or angiocath into the radial artery. Since the arterial catheter is placed into the artery using a needle, there will be mild to moderate discomfort. The total amount of blood drawn during the procedure is less than 100cc.

Additionally, subjects are asked to perform motions with their hand. Standard motions include tapping and rubbing at aperiodic intervals with amplitudes of 1‐2 cm and 1‐4 Hz with a random variation in frequency. The subject is instructed to tap (or rub) with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are recorded by the pressure pad system. Each plateau will have both an interval of tapping and rubbing.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title no Treatment
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
33.67  (8.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
14
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title SpO2 Accuracy During Motion Conditions - MaxA Sensor
Hide Description For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Accuracy Root Mean Square
1.78
2.Primary Outcome
Title SpO2 Accuracy During Motion Conditions - MaxN Sensor
Hide Description For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Accuracy Root Mean Square
1.93
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title no Treatment
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
no Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
no Treatment
Affected / at Risk (%)
Total   0/18 (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   1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
mild IV infiltration  1/18 (5.56%) 
[Not Specified]
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: 3034068955
EMail: michael.luna-victoria@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02247765     History of Changes
Other Study ID Numbers: COVMOPR0445
First Submitted: September 18, 2014
First Posted: September 25, 2014
Results First Submitted: February 15, 2016
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017