An interventional study of BIS 70 maintained and BIS level 50 in Respiration, Artificial, sponsored by The Cleveland Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-03-05.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention
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.
Patient will be selected from the ICU, based on the defined inclusion and exclusion criteria. Potential study subjects will be screened by the research fellow or the on-site study co-investigator. Eligible patients will be allocated to receive propofol sedation titrated to 3 different BIS levels in a random order. BIS XP monitors (Aspect Medical Systems, Norwood, MA, USA) will be used which are relatively resistant to EMG artifact; a BIS sensor will be position on forehead of the patient after the skin is degreased and gently abraded. Esophageal pressure monitoring will be performed by a catheter inserted from the nose to the esophagus and left there trough the study period.
If patients are on sedation they will be placed on propofol sedation for a washout period. Each patient will receive propofol sedation by continuous infusion titrated to a different levels of BIS in a randomized fashion according to a computer-generated random-number sequence;
All patients will otherwise receive routine ICU care and medications without interruption of standard clinical care.
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Exclusion Criteria:
BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);
Other: BIS 70 maintained
BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity)
Other: BIS level 50
BIS levels of 35 will be targeted (low frequency EEG activity)
Other: BIS 35
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.
Also known as: sedation, propofol, BIS monitor, esophageal pressure, esophageal function
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.
Also known as: sedation, propofol, BIS monitor, esophageal pressure, esophageal function
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.
Also known as: sedation, propofol, BIS monitor, esophageal pressure, esophageal function
Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
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.
Time frame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
Deepening propofol sedation - as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale - lowers esophageal pressure in critical care patients.
The SAS uses a 1 to 7 point scale to make a determination of the patient's level of agitation and sedation from a rating of 7 dangerously agitated to a rating of 1 unarousable (Table 1). Clinical sedation assessments using SAS and RASS scales will be measured every 10 minutes through the study period.
Time frame: every 10 minutes, while sedated in the ICU
Modifying the target level of BIS titration affects upper esophageal pressures and esophageal peristalsis.
Upper esophageal sphincter pressures, transient LES relaxations, and regurgitations will be evaluated by the GI team from recorded data from high resolution manometry.
Time frame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
There is an association between ventilator associated pneumonia and baseline lower esophageal and barrier pressure.
Patients will be followed for their stay in the hospital for occurrence of ventilator associated pneumonia.
Time frame: daily, until hospital discharge
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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