|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
P080009 / PAS001 |
Date Original Protocol Accepted |
03/29/2013
|
Date Current Protocol Accepted |
03/23/2015
|
Study Name |
Open Label PAS of SEDASYS Syst User Resp
|
Device Name |
SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This study is designed to evaluate the SEDASYS® System can be used safely in routine clinical practice by measuring the trained users responses to System alarms. The intent of this study, as well as the companion study, is to remove the Restriction of Use limiting initial use of the SEDASYS System to settings where an anesthesia provider is immediately available.
|
Study Population |
Up to 32 users in up to 15 sites.
|
Sample Size |
Accounting for a 3% patient dropout, the resulting sample size will be 866.
|
Key Study Endpoints |
The primary endpoint will be the percentage of documented responses to alarms. The secondary endpoint will be the sufficiency of response, which is measured by a score for success. Other Safety Endpoints: Adverse events (defined by MeDRA) and all hands-on airway rescue interventions by anesthesia providers will be reported. Stopping Rules: The study may be stopped by the Sponsor in the event of a single confirmed non-response to an alarm (desaturation, apnea, hypotension, bradycardia). Confirmation of a non- response will be determined by the EAC; assessment will include if the Data Acquisition System (DAQ) failed to record a response. The reason for failure to respond will be assessed by EES and continuance of the study will be based on this assessment. The expected rate of DAQ failure is approximately one percent. Confirmed non-responses will be sent to the Agency within 15 days of the EAC notifying the Sponsor.
|
Follow-up Visits and Length of Follow-up |
Duration of each subject's participation is approximately 2 days (one day participation and one day follow up).
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
51
|
Actual Number of Sites Enrolled |
1
|
Patient Follow-up Rate |
n/a
|
Final Safety Findings |
n/a
|
Final Effect Findings |
n/a
|
Study Strengths & Weaknesses |
n/a
|
Recommendations for Labeling Changes |
no
|