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NCT Number: NCT07219069

Bispectral Monitoring on Mechanically Ventilated Patients

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.

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Key information

Conditions

Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission to the medical ICU
  • Intubated on mechanical ventilation
  • On sedation medication infusion

Exclusion criteria

  • 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
  • Refractory shock: Mean arterial blood pressure below 65 millimeters of mercury(65mmHg) despite maximum doses of 3 pressors. Norepinephrine 70mcg/min; vasopressin 0.03 units/min; epinephrine 35mcg/min; dopamine 20mcg/kg/min and phenylephrine 350mcg/min
  • Inability to complete the required time for follow-up
  • Surgical admission diagnosis
  • Patients with skin conditions precluding BIS monitor sensor adherence
  • Patients on neuromuscular blockade infusion or benzodiazepine infusion

Treatment and study plan

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

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.

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Vidales

CONTACT

[email protected]

(713) 500-6851

Pascal L Kingah, MD, MPH

CONTACT

[email protected]

713 500 6828

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Bispectral Monitoring on Mechanically Ventilated Patients, a Randomized Clinical Trial. (BIMV Trial)

Acronym: BIMV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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