Clinical trial NCT01173263: Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
Official title: Effect of BIS Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiration, Artificial
Keywords: breathing machine
mechanical ventilator
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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;

1. BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);
2. BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity);
3. BIS levels of 35 will be targeted (low frequency EEG activity). A propofol infusion will be titrated by the investigators to the designated BIS target according to randomization. Clinical personnel will not be blinded to the study, and if patient has clinically significant change in hemodynamic parameters study will be interrupted. Each BIS target level will be kept as constant as possible for at least one hour; thereafter, lower esophageal pressures will be recorded for 15 minutes using high resolution esophageal manometry. Studies will be done in supine position \[Most ICU patients are now kept head-up.\], and the manometric assembly will be positioned to record from the hypopharynx to the stomach with 4-6 of the sensors positioned in the stomach.

All patients will otherwise receive routine ICU care and medications without interruption of standard clinical care.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* Written informed consent from relatives
* Clinically stable
* Mechanically ventilated \< 2days
* Require sedation and expected to be given propofol

Exclusion Criteria:

* Recent injury or other pathologic condition of the esophagus
* Major bronchopleural fistula
* History of liver failure
* History of renal failure
* History of major neuromuscular disease
* Multiple trauma
* Upper motor nerve injury
* Hypersensitivity to propofol
* Recent gastrointestinal surgery
* Patients with a diagnosed or suspected condition that may give false results in BIS monitoring.
* Tracheostomized patients

Primary outcomes:
measure: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
timeFrame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
Secondary outcomes:
measure: Deepening propofol sedation - as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale - lowers esophageal pressure in critical care patients.
timeFrame: every 10 minutes, while sedated in the ICU
measure: Modifying the target level of BIS titration affects upper esophageal pressures and esophageal peristalsis.
timeFrame: for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU
measure: There is an association between ventilator associated pneumonia and baseline lower esophageal and barrier pressure.
timeFrame: daily, until hospital discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Alparslan Turan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: