A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents

Study Overview
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Brief Summary
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This is a prospective, randomized, blinded study in which patients will be enrolled into either treated(BIS group) or untreated (non-BIS) group employing bispectral analysis to measure the level of sedation/analgesia in patients receiving neuromuscular blocking agents. To collect pertinent data on critically ill patients while they are receiving NMBA's. In particular to correlate sedation/analgesic medication needs between a group whose medication use is determined by the values obtained by bispectral analysis to a group who will have medications delivered by the standard of care presently used in the intensive care unit in which they are being treated. To document that patients who are monitored with bispectral analysis are able to achieve an appropriate level of consciousness in a shorter time and require less manipulation and amounts of sedative or analgesic medications than those who are not monitored.

Detailed Description
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This is a prospective, randomized and blinded study being done in order to help evaluate the level of consciousness with bispectral analysis (BIS) in ICU patients who are pharmacologically paralyzed with NMBAs (neuromuscular blockade agents) and to assess such things as the amount of time required to achieve the appropriate level of sedation/analgesia. Data will be collected and evaluated via this FDA approved equipment. The intent of this project is to evaluate this technology in those who are requiring anesthesia like states (use of NMBAs) for prolonged periods in the critically ill patient population.

Official Title
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A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents

Conditions
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ICU Patients

Intervention / Treatment
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* Device: BIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consented ICU patient, receiving neuromuscular blocking agents. Exclusion Criteria: Unable to be consented

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Standard of care | |
| Experimental: 2<br>Sedation based on BIS value, oer treating physician discretion. | Device: BIS<br>* Sedation dosing based on BIS value, oer treating physician discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of sedation required. |  | During period of neuromuscular blockade use in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time requiring neuromuscular blockade and mechanical ventilation. |  | Time in ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular blocking agents, Bispectral analysis