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

NCT ID: NCT01737190

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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The aim of the study is to examine the effects of two different levels of PEEP on subsequent standard recruitment maneuver.

Detailed Description

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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.

Conditions

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ARDS

Keywords

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esophageal pressure ARDSnet protocol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PEEP guided by Esophageal pressure + Recruitment maneuver

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Soroksky Arie

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arie Soroksky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wolfson MC

Locations

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E. Wolfson MC

Holon, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Arie Soroksky, M.D.

Role: primary

Other Identifiers

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0161-12-WOMC

Identifier Type: -

Identifier Source: org_study_id