Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients

Respiration, Artificial Clinical Trial

Official title:

Effect of BIS Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01173263
• Other study ID #: 10-226
• Status: Terminated
• Phase: N/A
• First received: July 21, 2010
• Last updated: March 4, 2014
• Start date: July 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiration, Artificial

Intervention

Other:
• BIS 70 maintained
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.
• BIS level 50
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.
• BIS 35
Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU	No
Secondary	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.	every 10 minutes, while sedated in the ICU	No
Secondary	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.	for 15 minutes after assigned BIS level has been maintained for one hour, while in the ICU	No
Secondary	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.	daily, until hospital discharge	No