SedationBIMVNCT07219069
Bispectral Monitoring on Mechanically Ventilated Patients
A study testing BIS group and Non-BIS group in people with Sedation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation
- What is being tested?
- BIS group and Non-BIS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the medical ICU
- Intubated on mechanical ventilation
- On sedation medication infusion
Who cannot join
- 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
Show all 9Show fewer
- Surgical admission diagnosis
- Patients with skin conditions precluding BIS monitor sensor adherence
- Patients on neuromuscular blockade infusion or benzodiazepine infusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Cypress Hospital
Cypress, Texas, 77433
Pascal L Kingah, MD, MPH, 713-500-6828, Pascal.L.Kingah@uth.tmc.edu
Elizabeth Vidales, (713) 500-6851, Elizabeth.Vidales@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Sedation
- Being tested
- BIS group, Non-BIS group
- Keywords
- sedation, Bispectral Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| BIS group | Experimental | Not described Receives: Device: BIS group |
| Non-BIS group | Active comparator | Not described Receives: Other: Non-BIS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median ventilator time reported in hours
Measured: 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
Measured: During ICU discharge or transfer out of ICU (about 5-7 days after admission to ICU)
Amount of sedation medication used
Measured: From start of ventilation to end of ventilation (about 4-6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start1 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Kingah, The University of Texas Health Science Center, Houston
- Investigators
- Pascal L Kingah, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219069
- Sponsor's protocol ID
- HSC-MS-25-0240
- Acronym
- BIMV
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Monitoring on Mechanically Ventilated Patients, a Randomized Clinical Trial. (BIMV Trial)
- ClinicalTrials.gov ID
- NCT07219069
- Acronym / sponsor ID
- BIMV / HSC-MS-25-0240
- Conditions
- Sedation
- Keywords
- sedation, Bispectral Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS group | Experimental | Device: BIS group |
| Non-BIS group | Active comparator | Other: Non-BIS group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to the medical ICU
- Intubated on mechanical ventilation
- On sedation medication infusion
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS groupParticipants 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 | Device | BIS group |
| Non-BIS groupThe 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. | Other | Non-BIS group |
Primary outcome
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)
2 secondary outcomes
ICU length of stay
Time frame: During ICU discharge or transfer out of ICU (about 5-7 days after admission to ICU)
Amount of sedation medication used
Time frame: From start of ventilation to end of ventilation (about 4-6 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal L Kingah, MD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS group and Non-BIS group in people with Sedation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal L Kingah, MD, MPH (713 500 6828, Pascal.L.Kingah@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.