Trial Outcomes & Findings for Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG (NCT NCT02639884)

NCT ID: NCT02639884

Last Updated: 2021-04-02

Results Overview

Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

One visit

Results posted on

2021-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Evaluation Group All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring SedLine EEG RRa monitoring
Overall Study STARTED	51
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evaluation Group n=47 Participants All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring.
Age, Continuous	52 years n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	37 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	35 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	47 participants n=99 Participants

PRIMARY outcome

Timeframe: One visit

Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.

Outcome measures

Outcome measures
Measure	Evaluation Group n=47 Participants All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring SedLine EEG RRa monitoring
Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected	47 Participants

PRIMARY outcome

Timeframe: One visit

All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals.

Outcome measures

Outcome measures
Measure	Evaluation Group n=47 Participants All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring SedLine EEG RRa monitoring
Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected	47 Participants

Adverse Events

Evaluation Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vikram Ramakanth

Masimo Corporation

Phone: 9492977416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60