We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Auditory Evoked Potential Monitoring on Bronchoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448811
First Posted: October 7, 2011
Last Update Posted: October 12, 2011
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.
Information provided by (Responsible Party):
Chien-Wei Hsu, Kaohsiung Veterans General Hospital.
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01448811


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chien-Wei Hsu, Assisted Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01448811     History of Changes
Other Study ID Numbers: VGHKS96-024
First Submitted: October 6, 2011
First Posted: October 7, 2011
Last Update Posted: October 12, 2011
Last Verified: October 2011