Trial Outcomes & Findings for Bispectral Index Monitoring During Testing in the Electrophysiology Lab (NCT NCT00749671)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

30 minutes

Results posted on

2016-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.	Ramsey Scale Monitoring Group assigned to sedation monitoring using the Ramsey Scale for ICD testing
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bispectral Index Monitoring During Testing in the Electrophysiology Lab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ICD Testingwith Bispectral Monitoring n=11 Participants Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.	Nurse Administered Moderate Sedation n=9 Participants Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ICD Testing n=11 Participants Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.	ICD testing2 n=9 Participants Ramsey Sedation Scale Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale.
Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes	4.27 units on a scale Interval 3.35 to 5.19	4.33 units on a scale Interval 3.33 to 5.33

SECONDARY outcome

Timeframe: 30 minutes

The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.

Outcome measures

Outcome measures
Measure	ICD Testing n=11 Participants Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.	ICD testing2 n=9 Participants Ramsey Sedation Scale Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale.
Patient Recall of Defibrillation Testing	0 percentage of patients with DFT recall	0 percentage of patients with DFT recall

Adverse Events

ICD Testingwith Bispectral Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nurse Administered Moderate Sedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James R. Cook MD

Baystate

Phone: 413-794-4492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place