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Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01668368
First received: July 23, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention
Acute Respiratory Failure
ARDS
Other: esophageal balloon

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Oxygenation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lung compliance, expressed as ml/cmH2O. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668368

Contacts
Contact: Arie Soroksky, M.D. 972-50-4056787 soroksky@gmail.com

Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Arie Soroksky, MD Wolfson MC
  More Information

Publications:
Responsible Party: Soroksky Arie, M.D., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01668368     History of Changes
Other Study ID Numbers: 0082-12-WOMC
Study First Received: July 23, 2012
Last Updated: August 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
ARDS
Esophageal pressure
pleural pressure
pulmonary compliance

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014