Status:
NOT_YET_RECRUITING
Bispectral Monitoring on Mechanically Ventilated Patients
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Sedation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Admission to the medical ICU
- Intubated on mechanical ventilation
- On sedation medication infusion
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07219069
Start Date
November 1 2025
End Date
November 1 2026
Last Update
October 21 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030