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.

Study Overview

• Status: Unknown
• Conditions: ARDS; Acute Respiratory Failure
• Intervention / Treatment: Other: esophageal balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arie Soroksky, M.D.; Phone Number: 972-50-4056787; Email: soroksky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: esophageal balloon; esophageal pressure as a surrogate for pleural pressure; Other Names: pleural pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oxygenation	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
lung compliance, expressed as ml/cmH2O.	1 year

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Arie Soroksky, MD, Wolfson MC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2012
• Last Update Submitted That Met QC Criteria: August 14, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: ARDS; Esophageal pressure; pleural pressure; pulmonary compliance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: 0082-12-WOMC