BIS-Guided Sedation Monitoring

Patients Who Are Mechanically Ventilated and Sedated Clinical Trial

Official title:

BIS-Guided Sedation Monitoring: A Prospective Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02045927
• Other study ID #: E-13-519
• Status: Terminated
• Phase: N/A
• First received: January 22, 2014
• Last updated: February 18, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Englewood Hospital and Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Patients Who Are Mechanically Ventilated and Sedated

Intervention

Other:
• sedation monitoring with RASS score

• sedation monitoring with BIS-Guided monitoring

Locations

Country	Name	City	State
United States	Englewood Hospital and Medical Center	Englewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Englewood Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of mechanical ventilation		from enrollment to extubation, an expected average of 4 days	No
Secondary	total sedation medication dose		from enrollment until extubation, an expected average of 4 days	No
Secondary	undersedation	measured by self-initiated medical support device removal, time in hours spent in physical restraints, or ventilator asynchrony	from enrollment to extubation, an expected average of 4 days	No

External Links

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