NCT07219069

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

October 6, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

October 6, 2025

Last Update Submit

October 17, 2025

Conditions

Sedation

Keywords

sedationBispectral Monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

Study Arms (2)

BIS group

EXPERIMENTAL
Device: BIS group

Non-BIS group

ACTIVE COMPARATOR
Other: Non-BIS group

Interventions

BIS groupDEVICE

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

BIS group
Non-BIS groupOTHER

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.

Non-BIS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

  • Pascal L Kingah, MD, MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal L Kingah, MD, MPH

CONTACT

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

Elizabeth Vidales

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 6, 2025

First Posted

October 21, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)