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Auditory Evoked Potential Monitoring on Bronchoscopy

This study has been completed.
Information provided by (Responsible Party):
Chien-Wei Hsu, Kaohsiung Veterans General Hospital. Identifier:
First received: October 6, 2011
Last updated: October 7, 2011
Last verified: October 2011
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 Intervention
Sedation Method Device: AEP monitor Procedure: Ramsay Sedation Scale

Study Type: Interventional
Study Design: 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

Further study details as provided by Chien-Wei Hsu, Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • 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:
  • mean propofol dose use during examination, times of propofol dose adjustment [ Time Frame: 40 minutes ]

Enrollment: 37
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
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Please refer to this study by its identifier: 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.
  More Information

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
Study First Received: October 6, 2011
Last Updated: October 7, 2011 processed this record on September 19, 2017