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

Sponsor

RWTH Aachen University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02617914

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Distress Syndrome / Severe ARDS Invasive Mechanical Ventilation Individualized PEEP Treatment Strategy	Procedure: individualized PEEP treatment, Invasive mechanical ventilation, ECMO,

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2018

Outcome Measures

Primary Outcome Measures

Hemodynamic changes in parameters of cardiac output [Within the first 6 hours after ICU admission]
Hemodynamic changes in parameters of pulmonary artery pressure [Within the first 6 hours after ICU admission]
Hemodynamic changes in parameters of left atrial pressures [Within the first 6 hours after ICU admission]
Hemodynamic changes in volumetric parameters [Within the first 6 hours after ICU admission]

Secondary Outcome Measures

ICU length of stay [Within 28 days after ICU admission]
Time of ventilator [Within 28 days after ICU admission]
Necessity of ECMO support [Within 28 days after ICU admission]
Hospital length of stay [Within 28 days after ICU admission]
28-day mortality [Within 28 days after ICU admission]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Male or female aged > 18 years
Written informed consent prior to study participation
The subject is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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