Bispectral Index Monitoring During Testing in the Electrophysiology Lab

NCT00749671 | Terminated Results

• 1 other identifier: 07-186
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been the standard of practice for patients undergoing a wide range of electrophysiology procedures during the past decade. Currently a subjective sedation assessment tool is the standard of practice within the Electrophysiology Lab (EP Lab). Bispectral Index monitoring (BIS) is an objective measure of the depth of sedation presently employed at Baystate Medical Center in the Intensive Care Unit and within the department of anesthesia. AIM The aim of this research study is to assess the utility of BIS monitoring in measuring the depth of sedation in patients undergoing defibrillation threshold testing (DFT). Our primary endpoint is: A change in OAAS scores of one point at the 30 minute data collection time period. Our secondary endpoints are: Lack of explicit recall of DFT testing and measurement of perioperative level of comfort. STUDY DESIGN AND SCOPE The population to be studied is those patients receiving a primary ICD implant or an ICD battery change with defibrillation threshold testing (DFT). All patients who have consented for ICD placement and DFT testing with moderate sedation will be invited to participate in this research study. Patients who are not candidates for DFT testing, as is determined by the EP physician, will be excluded from the study. Demographic data including: age, gender, BMI, current medications and history of sleep apnea will be collected. Data detailing the amount of drug administered during the procedure and any use of reversal agents, will be retrieved from the medical record. The study will be conducted within the Electrophysiology lab at Baystate Medical Center. An enrollment of 60 subjects is expected to be completed within 6 months. 30 patients will originate from the outpatient population and 30 from the inpatient. Follow up assessments using the OAAS scale will be completed at 30 min, 1 hour and 4 hours post procedure. Also, perioperative comfort and recall of DFT testing will be assessed at the 4 hour mark.

Conditions

Tachycardia, Ventricular

Outcome Measures

Primary Outcomes (1)

• Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes

  Sedation level was evaluated and graded according to the observer's assessment of alertness/sedation (OAAS) rating scale. This scale has 6 possible measures of consciousness: OAAS score 5-awake and responds readily to name spoken in normal tone. OAAS score 4-lethargic responses to name in normal tone. OAAS score 3-responds only after name is called loudly and/or repeatedly. OAAS score 2-responds only after name called loudly and mild shaking. OAAS score 1-does not respond when name is called loudly and mild shaking or prodding. OAAS score 0-does not respond to noxious stimulation.

  30 minutes

Secondary Outcomes (1)

• Patient Recall of Defibrillation Testing

  30 minutes

Study Arms (2)

ICD testing BIS

ACTIVE COMPARATOR

Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.

Device: Bispectral index monitoring

ICD testing Ramsey

ACTIVE COMPARATOR

Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT

Other: Ramsey Sedation Scale

Interventions

Bispectral index monitoring DEVICE

The monitoring of the EEG signal is designed to determine if the sedation is adequate.

ICD testing BIS

Ramsey Sedation Scale OTHER

The determination of the degree of sedation is accomplished using an established sedation scale.

ICD testing Ramsey

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who are having ICD placement and DFT testing will be invited to participate in this research study.

You may not qualify if:

• Patients who are not candidates for DFT testing, as is determined by the EP physician
• An example of such a patient would be one who is hemodynamically unstable;
• DFT testing is contraindicated in this case.

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: James R. Cook MD
• Organization: Baystate

james.cook@bhs.org

413-794-4492

Study Officials

• james cook, md

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, EP Lab

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: September 9, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 19, 2016
• Results First Posted: October 19, 2016

Record last verified: 2015-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)