N/A
N=51
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Obstructive Sleep Apnea (OSA)
Bottom Line
View on ClinicalTrials.gov: NCT02639884 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected — 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SedLine EEG (Device); RRa monitoring (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected |
47 | — |
| PRIMARY Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected |
47 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02639884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.