Trial Outcomes & Findings for Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion (NCT NCT02247765)

Last Updated: 2017-05-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

up to 6 months

Results posted on

2017-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	USB Pulse Oximetry Monitor Interface Cable 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.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	no Treatment n=18 Participants
Age, Continuous	33.67 years STANDARD_DEVIATION 8.25 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	18 participants n=93 Participants

PRIMARY outcome

Timeframe: up to 6 months

Outcome measures

Outcome measures
Measure	no Treatment n=18 Participants
SpO2 Accuracy During Motion Conditions - MaxA Sensor	1.78 Accuracy Root Mean Square

PRIMARY outcome

Timeframe: up to 6 months

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.

Outcome measures

Outcome measures
Measure	no Treatment n=18 Participants
SpO2 Accuracy During Motion Conditions - MaxN Sensor	1.93 Accuracy Root Mean Square

Adverse Events

no Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	no Treatment n=18 participants at risk
Skin and subcutaneous tissue disorders mild IV infiltration	5.6% 1/18

Additional Information

Michael Luna-Victoria

Medtronic

Phone: 3034068955

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place