BIS-Guided Sedation Monitoring

NCT02045927 | Terminated

• 1 other identifier: E-13-519
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Who Are Mechanically Ventilated and Sedated

Keywords

sedation; BIS; monitoring

Outcome Measures

Primary Outcomes (1)

• duration of mechanical ventilation

  from enrollment to extubation, an expected average of 4 days

Secondary Outcomes (2)

• total sedation medication dose

  from enrollment until extubation, an expected average of 4 days

• undersedation

  from enrollment to extubation, an expected average of 4 days

Study Arms (2)

Intevention Group

ACTIVE COMPARATOR

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

Other: sedation monitoring with RASS score; Other: sedation monitoring with BIS-Guided monitoring

Control Group

OTHER

sedation monitoring with RASS score

Other: sedation monitoring with RASS score

Interventions

sedation monitoring with RASS score OTHER

Control Group; Intevention Group

sedation monitoring with BIS-Guided monitoring OTHER

Intevention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Study Officials

• Carmine Gianatiempo, MD

  Englewood Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

US (1)