Bispectral Monitoring on Mechanically Ventilated Patients (BIMV)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sedation
• Intervention / Treatment: Device: BIS group; Other: Non-BIS group

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal L Kingah, MD, MPH; Phone Number: 713 500 6828; Email: Pascal.L.Kingah@uth.tmc.edu
• Study Contact Backup: Name: Elizabeth Vidales; Phone Number: (713) 500-6851; Email: Elizabeth.Vidales@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Elizabeth Vidales; Phone Number: (713) 500-6851; Email: Elizabeth.Vidales@uth.tmc.edu
      • Contact: Pascal L Kingah, MD, MPH; Phone Number: 713-500-6828; Email: Pascal.L.Kingah@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIS group	Device: 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
Active Comparator: Non-BIS group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median ventilator time reported in hours	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 Outcome Measures

Outcome Measure	Time Frame
ICU length of stay	During ICU discharge or transfer out of ICU (about 5-7 days after admission to ICU)
Amount of sedation medication used	From start of ventilation to end of ventilation (about 4-6 days)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Pascal L Kingah, MD, MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 6, 2025
• First Submitted That Met QC Criteria: October 17, 2025
• First Posted (Estimated): October 21, 2025

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: sedation; Bispectral Monitoring
• Other Study ID Numbers: HSC-MS-25-0240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No