Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

This study is not yet open for participant recruitment.
Verified August 2012 by Wolfson Medical Center
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

July 23, 2012
August 14, 2012
September 2012
September 2013   (final data collection date for primary outcome measure)
Oxygenation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01668368 on ClinicalTrials.gov Archive Site
lung compliance, expressed as ml/cmH2O. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance
Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance Approach Guided by Esophageal Pressure in Acute Respiratory Failure.

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Respiratory Failure
  • ARDS
Other: esophageal balloon
esophageal pressure as a surrogate for pleural pressure
Other Name: pleural pressure
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.

Intervention: Other: esophageal balloon
Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. Epub 2008 Nov 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Arie Soroksky, M.D. 972-50-4056787 soroksky@gmail.com
Not Provided
 
NCT01668368
0082-12-WOMC
No
Soroksky Arie, Wolfson Medical Center
Wolfson Medical Center
Not Provided
Principal Investigator: Arie Soroksky, MD Wolfson MC
Wolfson Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP