BIS-Guided Sedation Monitoring

NCT ID: NCT02045927

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief Summary

This study looks to assess whether monitoring sedation status in mechanically-ventilated Medical Surgical Intensive Care Unit (MSICU) patients using Bispectral index (BIS) monitor-augmented sedation monitoring as opposed to Richmond Agitation Sedation Scale (RASS) score is associated with decreased duration of mechanical ventilation.

Investigators hypothesize that using BIS monitors to help monitor depth of sedation in mechanically ventilated ICU patient will result in a decreased duration of mechanical ventilation when compared to solely utilizing clinical sedation scales such as RASS.

Detailed Description

Participants will be randomized into two groups, the intervention group will receive sedation monitoring with BIS monitoring plus RASS. The control group will receive sedation monitoring with RASS score only. Randomization will be accomplished through online randomization software.

For randomization purposes, the intervention group will be labeled as the "A" group. The control group will labeled as the "B" group. In the BIS-augmented group, sedation requirement will be titrated according to an average of BIS reading in the 5 minute period prior to assessment with a goal of maintaining a value of (60-70) in addition to a RASS score goal of (-1 to -2), provided no noxious stimulation such as endotracheal suctioning and/or wound dressing has occurred for at least 30 minutes, BIS values have been stable for at least 5 minutes, signal quality index (>80%), minimal EMG interference (<50%), patient is not shivering, and patient does not have warmer or other devices that may produce an electric current on their body or nearby. In the RASS group, sedation requirements will be titrated to maintain a RASS score of (-1 to -2), will be assessed via the nurse taking care of the patient provided no noxious stimulation has occurred for at least 30 minutes prior to assessment.

Both groups will have sedation assessment at least every 6 hours during a 12 hour shift and as needed as per ICU RN and/or physician. Nurses will be free to exercise their judgment if they deem that their patients require more or less sedation that is inconsistent with patient's BIS or RASS score, they will, however, be required to provide a rationale for their judgment and record such events on a special form created for this study.

Conditions

Patients Who Are Mechanically Ventilated and Sedated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intevention Group

sedation monitoring with RASS score plus sedation monitoring with BIS-Guided monitoring

Group Type: ACTIVE_COMPARATOR

sedation monitoring with RASS score

Intervention Type: OTHER

sedation monitoring with BIS-Guided monitoring

Intervention Type: OTHER

Control Group

sedation monitoring with RASS score

Group Type: OTHER

sedation monitoring with RASS score

Intervention Type: OTHER

Interventions

sedation monitoring with RASS score

Intervention Type: OTHER

sedation monitoring with BIS-Guided monitoring

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients >18 years of age.
• Patients expected to be mechanically ventilated and sedated with continuous intravenous infusions of Propofol or Midazolam and fentanyl for >= 24 hours within 12 hours of screening.

Exclusion Criteria

• Patients with Seizure disorders acute neurological injury, severe dementia or anoxic brain injury.
• Patients with tracheostomies.
• Patients requiring neuromuscular blocking agents (NMBA).
• Patients transferred from another ICU while mechanically ventilated.
• Patients with cardiac pacemakers.
• Peri-cardiac arrest patients.
• Patients with induced hypothermia.
• Pregnant patients.
• Patients with no known Legally Authorized Representative (LAR).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmine Gianatiempo, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital and Medical Center

Locations

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Countries

United States

Other Identifiers

E-13-519

Identifier Type: -

Identifier Source: org_study_id