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NCT01173263 · ClinicalTrials.gov registry record · NA
Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
A NA study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT01173263: Clinical Trial NA study, sponsored by The Cleveland Clinic.
NCT01173263 is a NA study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01173263, a NA study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
Primary Outcome
Sedation will also be evaluated with the bispectral index of the electroencephalogram. BIS of the EEG data will be acquired with 4 BIS-sensor electrodes and a BIS XP monitor. The BIS will be recorded electronically at one-minute intervals. Heart rate, blood pressures (diastolic and systolic), respiratory rate, core temperature and oxygen saturation will be recorded every 5 minutes during the measurement period of the study.
Interventions
- OTHER BIS 70 maintained
- OTHER BIS level 50
- OTHER BIS 35
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-03 |
| Phase | NA |
Why NCT01173263 stopped before completion
NCT01173263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which BIS 70 maintained is the first listed.
NCT01173263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01173263 about?
NCT01173263 is a clinical study titled "Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients". Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
What is the current status of trial NCT01173263?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2010-07. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01173263?
The interventions under investigation include: BIS 70 maintained (OTHER), BIS level 50 (OTHER), BIS 35 (OTHER).
Who is sponsoring clinical trial NCT01173263?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01173263's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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