Health TrialsbyHealthPanel

Bispectral Monitoring on Mechanically Ventilated Patients

ConditionSedation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to determine the difference in the duration of mechanical ventilation, to evaluate the difference in ICU length of stay and to determine the difference in the overall dose of sedation medications between the between participants who were monitored using Bispectral index monitoring (BIS) monitors and those who were not.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admission to the medical ICU

Intubated on mechanical ventilation

On sedation medication infusion

Disqualifiers

Patients with a history of chronic opioid use

Patients with end-stage liver disease at ICU admission (i.e., International normalized ratio >1.5 and not taking warfarin and/or a total serum bilirubin 1.5 times above normal limits)

Pregnant patients

Current prisoner

Trial design

Design model

Parallel

Treatments tested in this trial

  • BIS group

    Device

    Participants will be placed on BIS monitoring continuously until extubation, transfer to another facility, change in status to comfort measures, or if the patient expires. The BIS monitoring system offers a continuous processed electroencephalographic measurement used to assess cerebral activity and can monitor the electrophysiologic effects of sedation and anesthetics.BIS monitoring offers numerical values which have been validated to reflect various sedation levels. BIS levels range from 0 to 100 with greater than 100 corresponding to wakefulness. Values less than 60 indicate deep sedation and values less than 40 correspond to deep anesthesia

  • Non-BIS group

    Other intervention

    The usual protocol for titrating sedation will be followed using various sedation assessment scales such as Richmond Agitation Sedation Scale (RASS), Visual Analog Scale (VAS), Ramsay Sedation Scale (RSS), or Sedation Agitation Scale (SAS) per physicians choice.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: BIS groupExperimental treatment 1 intervention
Group B: Non-BIS groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Median ventilator time reported in hours

Time frame
from the time the patient was intubated to the time they were extubated, changed to comfort measures, transferred to another facility, or expired(about 4-6 days)

Secondary outcomes

1

ICU length of stay

Time frame
During ICU discharge or transfer out of ICU (about 5-7 days after admission to ICU)
2

Amount of sedation medication used

Time frame
From start of ventilation to end of ventilation (about 4-6 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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