Recruiting

BIS Monitoring

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07219069

Conditions

Sedation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BIS group

Non-BIS group

Study Details

Brief summary:

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.

Conditions

Sedation

Study ID

NCT07219069

Start date

Nov 1, 2025

Status verified date

Jun, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: BIS group

active comparator: Non-BIS group

Interventions

BIS group

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

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 outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Pascal L Kingah, MD, MPH

713 500 6828Pascal.L.Kingah@uth.tmc.edu

Elizabeth Vidales

(713) 500-6851Elizabeth.Vidales@uth.tmc.edu

Locations

Memorial Hermann Cypress Hospital

Recruiting

Cypress, Texas, United States, 77433

Contacts

Pascal L Kingah, MD, MPH

713-500-6828Pascal.L.Kingah@uth.tmc.edu

Elizabeth Vidales

(713) 500-6851Elizabeth.Vidales@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • sedation
  • Bispectral Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-06-25.