Back to resultsCorrelation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SedLine EEG
RRa monitoring
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea (OSA)
Eligibility Criteria
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.
Sites / Locations
- Stanford University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation Group
Arm Description
All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
Outcomes
Primary Outcome Measures
Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected
Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.
Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected
All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02639884
Brief Title
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Official Title
Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluation Group
Arm Type
Experimental
Arm Description
All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
Intervention Type
Device
Intervention Name(s)
SedLine EEG
Intervention Type
Device
Intervention Name(s)
RRa monitoring
Primary Outcome Measure Information:
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Drover, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
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