Auditory Evoked Potential Monitoring on Bronchoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448811
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
Chien-Wei Hsu, Kaohsiung Veterans General Hospital.

Brief Summary:
To compare the difference of sedation monitoring for bronchoscopic examination monitoring by auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated patients.

Condition or disease Intervention/treatment Phase
Sedation Method Device: AEP monitor Procedure: Ramsay Sedation Scale Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Impact of Auditory Evoked Potential Index Monitoring on Bronchoscopic Examination in the Mechanical Ventilated Patients - A Prospective, Randomized, Controlled Study
Study Start Date : March 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: AEP monitoring Device: AEP monitor
In AEP monitoring group, nurses adjusted propofol dose according to AAI values. If AAI>40, titrate up propofol dosage, AAI<25, titrated down propofol dosage.
Active Comparator: RSS monitoring Procedure: Ramsay Sedation Scale
During bronchoscopy, nurses adjusted propofol dose according to Ramsay Sedation Scale.

Primary Outcome Measures :
  1. Change of mean arterial pressure, heart rate and AAI [ Time Frame: 40 minutes ]
    During bronchoscopy, we recorded AAI number, blood pressure and heart rate every 5 minutes, totally up to 40 minutes.

Secondary Outcome Measures :
  1. mean propofol dose use during examination, times of propofol dose adjustment [ Time Frame: 40 minutes ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mechanically ventilated patients with aged 18 or over and they needed bronchoscopic examination in the ICU were eligible for this study.

Exclusion Criteria:

  • patients with pacemaker, neuromuscular blockades, propofol allergy or hearing impairment.

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 identifier (NCT number): NCT01448811

Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Principal Investigator: Chien-Wei Hsu, MD Kaohsiung Veterans General Hospital.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chien-Wei Hsu, Assisted Professor, Kaohsiung Veterans General Hospital. Identifier: NCT01448811     History of Changes
Other Study ID Numbers: VGHKS96-024
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011