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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Device: SedLine EEG; Device: RRa monitoring

• Registration Number: NCT02639884
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2021-01-06
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Results First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation Group	RRa monitoring	All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring
Evaluation Group	SedLine EEG	All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States