Auditory Evoked Potential Monitoring on Bronchoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chien-Wei Hsu, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01448811
First received: October 6, 2011
Last updated: October 7, 2011
Last verified: October 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Change of mean arterial pressure, heart rate and AAI [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Kaohsiung Veterans General Hospital.

Additional 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
Study First Received: October 6, 2011
Last Updated: October 7, 2011
Health Authority: Taiwan: Health Department of Executive Yuan

ClinicalTrials.gov processed this record on July 28, 2014