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

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639884
• Other study ID #: DROV0007
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea, Obstructive

Intervention

Device:
• SedLine EEG

• RRa monitoring

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One visit
Primary	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.	One visit