Bispectral Monitoring on Mechanically Ventilated Patients (BIMV)

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Sedation

Treatments: Other: Non-BIS group; Device: BIS group

Study type: Interventional

Funder types: Other

Identifiers

NCT07219069

HSC-MS-25-0240

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

BIS group

Experimental group

Treatment:

Device: BIS group

Non-BIS group

Active Comparator group

Treatment:

Other: Non-BIS group