Trial Outcomes & Findings for Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion (NCT NCT02382133)

NCT ID: NCT02382133

Last Updated: 2017-06-07

Results Overview

accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2017-06-07

Participant Flow

Participant milestones

Measure	Nasal Alar Oxygen Sensor Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor
Overall Study STARTED	43
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Measure	Nasal Alar Oxygen Sensor Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor
Overall Study Death	22
Overall Study transfer out of ICU	4
Overall Study Physician Decision	2
Overall Study arterial catheter loss	4
Overall Study pressure injury both sites	1

Baseline Characteristics

Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion

Baseline characteristics by cohort

Measure	Nasal Alar Oxygen Sensor n=43 Participants Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=93 Participants
Age, Categorical >=65 years	19 Participants n=93 Participants
Age, Continuous	60.1 years STANDARD_DEVIATION 16.1 • n=93 Participants
Sex: Female, Male Female	26 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Region of Enrollment United States	43 Participants n=93 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Nasal sensor unable to obtain a signal 7% of measures on enrollment, Forehead sensor unable to obtain signal 32% of measures on enrollment.

accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures

Outcome measures

Measure	Nasal Alar Oxygen Sensor n=43 Participants Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor
Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation	43 Participants

SECONDARY outcome

Timeframe: 5 days

Population: incidence of any pressure injury

assessment for development of pressure ulcer at forehead sensor, "OxiMaxTM, Nellcor,Covidien" and nasal alar sensor, "Alar One-SenseTM, Xhale Assurance"

Outcome measures

Measure	Nasal Alar Oxygen Sensor n=43 Participants Application of a nasal alar oxygen sensor Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor
Device Related Pressure Ulcer	2 participants

Adverse Events

Nasal Alar Oxygen Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marilyn Schallom

Barnes-Jewish Hospital

Phone: 314-286-0835

Email: marilyn.schallom@bjc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place