Hemodynamic and Cardiac Effects of Individualized PEEP Titration Using Esophageal Pressure Measurements in ARDS Patients (ENCODE)

April 24, 2017 updated by: RWTH Aachen University

The acute respiratory distress syndrome (ARDS) is common condition in critical ill patients affecting 7.2 people / 100,000 population / year and more than 7% of patients with invasive mechanical ventilation for more than 24 hours. ARDS carries a high hospital mortality of up to 48% and consumes large amounts of critical care resources. ARDS patients often present with severe hypoxemia that is refractory to conventional treatment and are thus evaluated for extracorporeal membrane oxygenation (ECMO). However, uncertainty regarding the appropriate indication for ECMO and clinical evidence for ECMO as a rescue treatment are still controversial. In 2012 Grasso and colleagues therefore presented a case series of influenza A (H1N1) ARDS patients describing the use of esophageal pressure measurements for individualized PEEP titration to achieve an end expiratory plateau pressure of the lung (PPLATL) of 25cm H2O. After performing the measurements in 14 patients, ventilator settings could be adjusted in half of these patients by increasing PEEP which resulted in an increase of oxygenation measures to an extend that criteria for extracorporeal support where no longer met and conventional treatment with invasive mechanical ventilation could be continued. However, uncertainty remains as to whether these results are generalizable to ARDS of any cause. In addition, increasing PEEP might impact on cardiac function and might therefore be associated with clinical important hemodynamic effects in these patients.

The investigators aim to evaluate hemodynamic changes in patients with severe ARDS in which an individualized PEEP treatment strategy can be employed. ARDS will be defined and stratified according to the Berlin ARDS definition. A naso-gastric probe capable of measuring esophageal pressure will be inserted directly after admission to the ICU as previously described. Invasive mechanical ventilation and oesophageal pressure measurements will be done using the GE Healthcare Carescape R860 ventilator. A pulmonary artery catheters (Edwards CCOcomb) will be inserted to evaluate the hemodynamic parameters of cardiac output, pulmonary artery pressures and left atrial pressures. Volumetric parameters will be measured using tanspulmonary thermodilution devices (Edwards EV1000). Cardiac function will be addressed in addition by the use of a predefined echocardiography protocol.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients referred to our ICU (Criitical Care Unit) for treatment of ARDS of any cause with a P/F ratio < 150 and indication for continued maximum critical care therapy. Patients of childbearing age with ARDS will be included.

Description

Inclusion Criteria:

  1. Patients referred to our ICU for treatment of ARDS of any cause with a P/F ratio < 150 and indication for continued maximum critical care therapy
  2. Male or female aged > 18 years
  3. Written informed consent prior to study participation
  4. The subject is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

  1. Patients admitted for primarily left ventricular or biventricular heart failure who are exclusively in need of cardiac and not pulmonary mechanical assist
  2. Pregnant and lactating females
  3. Patient has been committed to an institution by legal or regulatory order
  4. Participation in a parallel interventional clinical trial
  5. The subject received an investigational drug within 30 days prior to inclusion into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemodynamic changes in parameters of cardiac output
Time Frame: Within the first 6 hours after ICU admission
Within the first 6 hours after ICU admission
Hemodynamic changes in parameters of pulmonary artery pressure
Time Frame: Within the first 6 hours after ICU admission
Within the first 6 hours after ICU admission
Hemodynamic changes in parameters of left atrial pressures
Time Frame: Within the first 6 hours after ICU admission
Within the first 6 hours after ICU admission
Hemodynamic changes in volumetric parameters
Time Frame: Within the first 6 hours after ICU admission
Within the first 6 hours after ICU admission

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU length of stay
Time Frame: Within 28 days after ICU admission
Within 28 days after ICU admission
Time of ventilator
Time Frame: Within 28 days after ICU admission
Within 28 days after ICU admission
Necessity of ECMO support
Time Frame: Within 28 days after ICU admission
Within 28 days after ICU admission
Hospital length of stay
Time Frame: Within 28 days after ICU admission
Within 28 days after ICU admission
28-day mortality
Time Frame: Within 28 days after ICU admission
Within 28 days after ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Alexander Kersten, MD, Department of Cardiology, Pneumology, Vascular Medicine and Critical Care (Medical Clinic I), University Hospital Aachen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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