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

NCT01173263 | Terminated DMC

• 1 other identifier: 10-226
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration, Artificial

Keywords

breathing machine; mechanical ventilator

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Deepening propofol sedation - as measured by Sedation Agitation Scale, Richmond Agitation Scale Score, and Ramsay sedation scale - lowers esophageal pressure in critical care patients.

  every 10 minutes, while sedated in the ICU

• Modifying the target level of BIS titration affects upper esophageal pressures and esophageal peristalsis.

  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.

  daily, until hospital discharge

Study Arms (3)

BIS 70

ACTIVE COMPARATOR

BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);

Other: BIS 70 maintained

BIS 50

ACTIVE COMPARATOR

BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity)

Other: BIS level 50

BIS 35

ACTIVE COMPARATOR

BIS levels of 35 will be targeted (low frequency EEG activity)

Other: BIS 35

Interventions

BIS 70 maintained OTHER

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

BIS 70

BIS level 50 OTHER

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

BIS 50

BIS 35 OTHER

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

BIS 35

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Propofol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alparslan Turan, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)