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Patients Who Are Mechanically Ventilated and Sedated | BIS-Guided Sedation Monitoring

Patients Who Are Mechanically Ventilated and Sedated research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Patients Who Are Mechanically Ventilated and Sedated

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:sedation monitoring with RASS score

Other:sedation monitoring with BIS-Guided monitoring

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Control Groupsedation monitoring with RASS score

Study Status

Terminated

Start Date: January 2014

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: duration of mechanical ventilation

Secondary Outcome: total sedation medication dose

Study sponsors, principal investigator, and references

Principal Investigator: Carmine Gianatiempo, MD

Lead Sponsor: Englewood Hospital and Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02045927

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