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

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ClinicalTrials.gov Identifier: NCT02639884
Recruitment Status : Completed
First Posted : December 28, 2015
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking Endoscopy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. electroencephalogram (EEG) signals [ Time Frame: up to 24 weeks. ]
  2. Acoustic Respiratory Rate (RRa) signals [ Time Frame: up to 24 weeks. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639884


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Masimo Corporation
Investigators
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Principal Investigator: David R Drover, M.D. Stanford University
More Information
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Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT02639884    
Other Study ID Numbers: DROV0007
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Airway Obstruction
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Insufficiency