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Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

NCT ID: NCT01668368

Last Updated: 2012-08-20

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Respiratory Failure ARDS

Keywords

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ARDS Esophageal pressure pleural pressure pulmonary compliance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

esophageal balloon

Intervention Type OTHER

esophageal pressure as a surrogate for pleural pressure

Interventions

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esophageal balloon

esophageal pressure as a surrogate for pleural pressure

Intervention Type OTHER

Other Intervention Names

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pleural pressure

Eligibility Criteria

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Inclusion Criteria

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.
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

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arie Soroksky, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson MC

Central Contacts

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Arie Soroksky, M.D.

Role: CONTACT

Phone: 972-50-4056787

Email: [email protected]

References

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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. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.

Reference Type RESULT
PMID: 19001507 (View on PubMed)

Other Identifiers

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0082-12-WOMC

Identifier Type: -

Identifier Source: org_study_id