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Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

Primary Purpose

Acute Respiratory Failure, ARDS

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

esophageal balloon

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring ARDS, Esophageal pressure, pleural pressure, pulmonary compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Esophageal balloon group

Arm Description

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.

Outcomes

Primary Outcome Measures

Oxygenation

Secondary Outcome Measures

lung compliance, expressed as ml/cmH2O.

Full Information

NCT ID

NCT01668368

First Posted

July 23, 2012

Last Updated

August 14, 2012

Sponsor

Wolfson Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01668368

Brief Title

Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

Official Title

Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance Approach Guided by Esophageal Pressure in Acute Respiratory Failure.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wolfson Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure, ARDS

Keywords

ARDS, Esophageal pressure, pleural pressure, pulmonary compliance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Esophageal balloon group

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

esophageal balloon

Other Intervention Name(s)

pleural pressure

Intervention Description

esophageal pressure as a surrogate for pleural pressure

Primary Outcome Measure Information:

Title

Oxygenation

Time Frame

1 year

Secondary Outcome Measure Information:

Title

lung compliance, expressed as ml/cmH2O.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arie Soroksky, M.D.

Phone

972-50-4056787

soroksky@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arie Soroksky, MD

Organizational Affiliation

Wolfson MC

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19001507

Citation

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.

Results Reference

result

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Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance

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