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PEEP Guided by Esophageal Balloon Measurement and Its Effect on Recruitment Maneuver

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Soroksky Arie, Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737190
First Posted: November 29, 2012
Last Update Posted: November 29, 2012
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.
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center
  Purpose
The aim of the study is to examine the effects of two different levels of PEEP on subsequent standard recruitment maneuver.

Condition Intervention
ARDS Other: PEEP guided by Esophageal pressure + Recruitment maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEEP Guided by Esophageal Balloon Measurement and Its Effect on Recruitment Maneuver

Further study details as provided by Soroksky Arie, Wolfson Medical Center:

Primary Outcome Measures:
  • oxygenation [ Time Frame: 4 hours ]
    the primary end point in both groups will be oxygenation improvement after each intervention in each arm.


Secondary Outcome Measures:
  • lung compliance [ Time Frame: 4 hours ]
    after each intervention lung compliance will be assessed.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEEP guided by Esophageal pressure + Recruitment maneuver.

Upon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiarory pressure of not more than 5 cm H2O.

A recruitment maneuver with application of 40 cm H2O for up to 40 seconds will be performed.

Other: PEEP guided by Esophageal pressure + Recruitment maneuver

Upon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiarory pressure of not more than 5 cm H2O.

A recruitment maneuver with application of 40 cm H2O for up to 40 seconds will be performed.


Detailed Description:

In this study we will examine the effects of two levels of PEEP on subsequent recruitment maneuver. In the first group a recruitment maneuver will be performed in patients who are ventilated with PEEP level set according to the ARDS network algorithm.

Patients will then be crossed over to a study arm where another recruitment maneuver will be performed while PEEP is adjusted according to esophageal pressure measurements.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

20 Man and women older than 18 years will be recruited.

Patients with acute respiratory failure of any cause who are mechanically ventilated according to the ARDS network recommendations will be considered for inclusion to the study.

To be included in the study a prerequisite of high peak Inspiratory pressure (plateau pressure of 25 to 30 cmH2O) has to be present, and at least one of the following four severity inclusion criteria has to be met.

1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 - PaO2 /FIO2 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 will be 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
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 ClinicalTrials.gov identifier (NCT number): NCT01737190


Locations
Israel
E. Wolfson MC Not yet recruiting
Holon, Israel, 58100
Contact: Arie Soroksky, M.D.    972-3-5028770    soroksky@gmail.com   
Principal Investigator: Arie Soroksky, M.D.         
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Arie Soroksky, M.D. Wolfson MC
  More Information

Responsible Party: Soroksky Arie, Dr., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01737190     History of Changes
Other Study ID Numbers: 0161-12-WOMC
First Submitted: November 26, 2012
First Posted: November 29, 2012
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Soroksky Arie, Wolfson Medical Center:
esophageal pressure
ARDSnet protocol