Assessing Respiratory Variability During Mechanical Ventilation in Acute Lung Injury (ALI)

NCT01083355 | Withdrawn

• 1 other identifier: H-29278
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy biological systems are characterized by a normal range of "variability" in organ function. For example, many studies of heart rate clearly document that loss of the normal level of intrinsic, beat-to-beat variability in heart rate is associated with poor prognosis and early death. Unlike the heart, little is known about patterns of respiratory variability in illness. What is known is that, like the heart, healthy subjects have a specific range of variability in breath- to-breath depth and timing. Additionally, in animal models, ventilator strategies that re-introduce normal variability to the breathing pattern significantly reduce ventilator-associated lung injury. Critically ill patients requiring mechanical ventilation offer an opportunity to observe and analyze respiratory patterns in a completely non-invasive manner. Current mechanical ventilators produce real-time output of respiratory tracings that can analyzed for variability. The investigators propose to non-invasively record these tracings from patients ventilated in the intensive care units for mathematical variability analysis. The purpose of these pilot analyses are to: (1) demonstrate the range of respiratory variability present in the mechanically ve ventilated critically ill and (2) demonstrate the ventilator modality that delivers or permits the closest approximation to previously described beneficial or normal levels of variability. Future studies will use this pilot data in order to determine if the observed patterns of respiratory variability in mechanically ventilated critically ill subjects have prognostic or therapeutic implications.

Conditions

Acute Lung Injury; Adult Respiratory Distress Syndrome

Keywords

Variable ventilation; Pressure regulated volume control ventilation; Airway pressure release ventilation

Outcome Measures

Primary Outcomes (1)

• The degree of variability in tidal volume (measured as % variation about the mean) stratified by ventilator mode.

  1 hour

Secondary Outcomes (2)

• Alternative measures of variability and complexity for each ventilator mode.

  1 hour

• Correlations between clinical parameters such as disease severity, vital signs, sedation levels, and variability.

  1 hour

Study Arms (1)

Mechanical ventilation

Critical care patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to adult medical, surgical, and coronary critical care units at Boston Medical Center.

You may qualify if:

• Age \> or equal to 18.
• Requires mechanical ventilation.
• Admitted to surgical, medical, or coronary critical care unit
• Triggering ventilator above set rate
• Meets American European consensus definition of acute lung injury: PaO2/FiO2 ratio \<300 or SaO2/FiO2 ratio\<315; bilateral infiltrates on chest x-ray (CXR); no congestive heart failure (CHF).

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Davis JN, Stagg D. Interrelationships of the volume and time components of individual breaths in resting man. J Physiol. 1975 Feb;245(2):481-98. doi: 10.1113/jphysiol.1975.sp010857.

  PMID: 1142186 BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• George O'Connor, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

US (1)