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Auditory Evoked Potential Monitoring on Bronchoscopy

NCT ID: NCT01448811

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sedation Method

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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AEP monitoring

Group Type EXPERIMENTAL

AEP monitor

Intervention Type 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.

RSS monitoring

Group Type ACTIVE_COMPARATOR

Ramsay Sedation Scale

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DEVICE

Ramsay Sedation Scale

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Chien-Wei Hsu

Assisted Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chien-Wei Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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Hsu CW, Sun SF, Chu KA, Lee DL, Wong KF. Monitoring sedation for bronchoscopy in mechanically ventilated patients by using the Ramsay sedation scale versus auditory-evoked potentials. BMC Pulm Med. 2014 Feb 6;14:15. doi: 10.1186/1471-2466-14-15.

Reference Type DERIVED
PMID: 24499010 (View on PubMed)

Other Identifiers

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VGHKS96-024

Identifier Type: -

Identifier Source: org_study_id