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: May 25, 2013
Last verified: May 2013

May 31, 2012
May 25, 2013
January 2012
April 2012   (final data collection date for primary outcome measure)
  • Response times [ Time Frame: Continuously shortly before (baseline) ] [ Designated as safety issue: No ]
    Response time between non-noxious stimulus and activation of handset device
  • response time [ Time Frame: during induction of anesthesia ] [ Designated as safety issue: No ]
    Response time between non-noxious stimulus and activation of handset device
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
Complete list of historical versions of study NCT01778608 on ClinicalTrials.gov Archive Site
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Feasability Test of a Handset Device to Detect Levels of Sedation and Loss of Consciousness
Feasibility Test of a Handset Device to Detect Sedation Levels and Loss of Consciousness During Propofol Administration

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Twenty patients requiring anaesthesia for clinical surgical care. ASA physical status I, II or III

Conscious Sedation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 50-72 years

Exclusion Criteria:

  • volunteer refusal
  • patient age >72 years
  • significant cardiovascular or respiratory disease
  • latex allergy
Both
50 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01778608
PCS-001
No
MMRF Struys, University Medical Centre Groningen
University Medical Centre Groningen
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University Medical Centre Groningen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP