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Completed

NCT Number: NCT01448811

Auditory Evoked Potential Monitoring on Bronchoscopy

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.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 813

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AEP monitor

Device

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.

Ramsay Sedation Scale

Procedure

During bronchoscopy, nurses adjusted propofol dose according to Ramsay Sedation Scale.

Primary outcomes

  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 outcomes

  1. mean propofol dose use during examination, times of propofol dose adjustment

    Time frame: 40 minutes

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Impact of Auditory Evoked Potential Index Monitoring on Bronchoscopic Examination in the Mechanical Ventilated Patients - A Prospective, Randomized, Controlled Study

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 7, 2011
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.