Feasability Test of a Handset Device to Detect Levels of Sedation and Loss of Consciousness

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

MMRF Struys, University Medical Centre Groningen

ClinicalTrials.gov Identifier:

NCT01778608

First received: May 31, 2012

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 31, 2012
Last Updated Date	January 24, 2013
Start Date ^ICMJE	January 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 24, 2013)	Response times [ Time Frame: Continuously shortly before (baseline) and during induction of anesthesia ] [ Designated as safety issue: No ] Response time between non-noxious stimulus and activation of handset device
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01778608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Feasability Test of a Handset Device to Detect Levels of Sedation and Loss of Consciousness
Official Title ^ICMJE	Feasibility Test of a Handset Device to Detect Sedation Levels and Loss of Consciousness During Propofol Administration
Brief Summary	Sedation is often administered to relieve anxiety and discomfort during uncomfortable procedures in elderly patients. Patient control of sedation offers many potential benefits for patients and healthcare professionals, including improved safety and patient satisfaction. The investigators overall goal is to develop a patient controlled intravenous sedation system that is effective but very safe for the patient, and requires minimal supervision by a doctor or nurse. To fulfill these criteria, a sedation system should incorporate fail-safe safety mechanisms. A key safety-critical component is a method of objectively assessing the degree of sedation of the patient, and of preventing him from self-administering unsafe doses of the sedative drug. The investigators have designed a new sedation system that uses a measure of the speed of response of the patient to a defined non-noxious stimulus to determine whether or not it is safe to allow him to self-administer further levels of sedation. Before being able to execute a volunteer study in order to determine a rational selection of optimal threshold response time, a feasibility test on the handset device is required.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Twenty patients requiring anaesthesia for clinical surgical care. ASA physical status I, II or III
Condition ^ICMJE	Conscious Sedation
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: age 50-72 years Exclusion Criteria: volunteer refusal patient age >72 years significant cardiovascular or respiratory disease latex allergy
Gender	Both
Ages	50 Years to 72 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01778608
Other Study ID Numbers ^ICMJE	PCS-001
Has Data Monitoring Committee	No
Responsible Party	MMRF Struys, University Medical Centre Groningen
Study Sponsor ^ICMJE	University Medical Centre Groningen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Medical Centre Groningen
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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