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

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02639884
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea (OSA)	Device: SedLine EEG; Device: RRa monitoring	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evaluation Group All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring	Device: SedLine EEG; Device: RRa monitoring

Outcome Measures

Primary Outcome Measures

1. Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected [One visit]

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

2. Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected [One visit]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.

• Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.

Exclusion Criteria:

• ASA classification higher than III.

• Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit

• Inability to obtain any physiological, vital, demographics and real time anaesthesia data

• Subjects who have known intolerance to any of the drugs to be used according to the study protocol

• Subjects deemed not suitable for study at the discretion of the Principal Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Stanford	California	United States	94305

Sponsors and Collaborators

• Masimo Corporation

Investigators

• Principal Investigator: David R Drover, M.D., Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 14, 2017

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT02639884
• Other Study ID Numbers: DROV0007
• First Posted: Dec 28, 2015
• Last Update Posted: Apr 2, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Sleep Apnea, Obstructive; Airway Obstruction

Study Results

Participant Flow

Arm/Group Title	Evaluation Group
Arm/Group Description	All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring SedLine EEG RRa monitoring
Period Title: Overall Study
STARTED	51
COMPLETED	47
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Evaluation Group
Arm/Group Description	All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring.
Overall Participants	47
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	52
Sex: Female, Male (Count of Participants)
Female	10 21.3%
Male	37 78.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.1%
Asian	5 10.6%
Native Hawaiian or Other Pacific Islander	1 2.1%
Black or African American	3 6.4%
White	35 74.5%
More than one race	0 0%
Unknown or Not Reported	2 4.3%
Region of Enrollment (participants) [Number]
United States	47 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected
Description	Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.
Time Frame	One visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluation Group
Arm/Group Description	All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring SedLine EEG RRa monitoring
Measure Participants	47
Count of Participants [Participants]	47 100%

2. Primary Outcome

Title	Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected
Description	All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals.
Time Frame	One visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evaluation Group
Arm/Group Description	All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
Measure Participants	47
Count of Participants [Participants]	47 100%

Adverse Events

Time Frame	During the data collection period, which could of lasted up to 8 hours.
Arm/Group Title	Evaluation Group
Arm/Group Description	All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
All Cause Mortality
	Evaluation Group
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Serious Adverse Events
	Evaluation Group
	Affected / at Risk (%)	# Events
Total	0/51 (0%)
Other (Not Including Serious) Adverse Events
	Evaluation Group
	Affected / at Risk (%)	# Events
Total	0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.