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Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01668368
Recruitment Status : Unknown
Verified August 2012 by Soroksky Arie, Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center

Brief Summary:
Patients with acute respiratory failure exhibiting decreased respiratory system compliance with hypoxemia or carbon dioxide retention are often difficult to ventilate with current guidelines that limit applied plateau pressure Yet, these guidelines do not take into consideration chest wall mechanics. The investigators sought to determine whether partition of the respiratory system into its components by measuring esophageal pressure and thus assessment of pleural pressure, would help in patients with acute respiratory failure to identify the factors contributing to low respiratory system compliance.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure ARDS Other: esophageal balloon Not Applicable

Detailed Description:

Identifying the dominant factor affecting respiratory system compliance by measuring transpulmonary pressure may better direct and optimize mechanical ventilation. Thus, instead of limiting mechanical ventilation by plateau pressure, PEEP and Inspiratory pressure adjustment would be individualized specifically for each patient's lung compliance as indicated by transpulmonary pressure.

The main goal of this approach is to specifically target transpulmonary pressure instead of plateau pressure, and therefore achieve the best Lung compliance with the least transpulmonary pressure possible.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance Approach Guided by Esophageal Pressure in Acute Respiratory Failure.
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Arm Intervention/treatment
Esophageal balloon group

Esophageal balloon will be inserted, and esophageal pressure will be measured in patients with acute respiratory failure.

Intervention - PEEP and Inspiratory pressure will be adjusted according to the measured esophageal pressure.

Other: esophageal balloon
esophageal pressure as a surrogate for pleural pressure
Other Name: pleural pressure

Primary Outcome Measures :
  1. Oxygenation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. lung compliance, expressed as ml/cmH2O. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of up to 30 cmH2O) had to be present, and at least one of the following four inclusion criteria had to be met.

    1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - P/F ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain SaO2 of > 90%. 4 - PCO2 over 60 mmHg, or PH less than 7.2 that is attributed to respiratory acidosis.

Exclusion Criteria:

  • Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01668368

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Contact: Arie Soroksky, M.D. 972-50-4056787

Sponsors and Collaborators
Wolfson Medical Center
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Principal Investigator: Arie Soroksky, MD Wolfson MC
Publications of Results:
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Responsible Party: Soroksky Arie, M.D., Wolfson Medical Center Identifier: NCT01668368    
Other Study ID Numbers: 0082-12-WOMC
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012
Keywords provided by Soroksky Arie, Wolfson Medical Center:
Esophageal pressure
pleural pressure
pulmonary compliance
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases