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

Invasive Mechanical Ventilation Clinical Trial

— ENCODE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02617914
• Other study ID #: 15-122
• Status: Withdrawn
• Phase: N/A
• First received: November 23, 2015
• Last updated: April 24, 2017
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Individualized PEEP Treatment Strategy
• Invasive Mechanical Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Severe Acute Respiratory Distress Syndrome / Severe ARDS

Intervention

Procedure:
• individualized PEEP treatment, Invasive mechanical ventilation, ECMO,

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

References & Publications (9)

Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guérin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine).. The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI. Review. — View Citation

Dalton HJ, MacLaren G. Extracorporeal membrane oxygenation in pandemic flu: insufficient evidence or worth the effort? Crit Care Med. 2010 Jun;38(6):1484-5. doi: 10.1097/CCM.0b013e3181e08fff. — View Citation

Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. Epub 2012 Aug 25. Erratum in: Intensive Care Med. 2012 Oct;38(10):1731-2. — View Citation

Grasso S, Terragni P, Birocco A, Urbino R, Del Sorbo L, Filippini C, Mascia L, Pesenti A, Zangrillo A, Gattinoni L, Ranieri VM. ECMO criteria for influenza A (H1N1)-associated ARDS: role of transpulmonary pressure. Intensive Care Med. 2012 Mar;38(3):395-403. doi: 10.1007/s00134-012-2490-7. Epub 2012 Feb 10. — View Citation

Hubmayr RD, Farmer JC. Should we "rescue" patients with 2009 influenza A(H1N1) and lung injury from conventional mechanical ventilation? Chest. 2010 Apr;137(4):745-7. doi: 10.1378/chest.09-2915. — View Citation

Mitchell MD, Mikkelsen ME, Umscheid CA, Lee I, Fuchs BD, Halpern SD. A systematic review to inform institutional decisions about the use of extracorporeal membrane oxygenation during the H1N1 influenza pandemic. Crit Care Med. 2010 Jun;38(6):1398-404. doi: 10.1097/CCM.0b013e3181de45db. Review. — View Citation

Noah MA, Peek GJ, Finney SJ, Griffiths MJ, Harrison DA, Grieve R, Sadique MZ, Sekhon JS, McAuley DF, Firmin RK, Harvey C, Cordingley JJ, Price S, Vuylsteke A, Jenkins DP, Noble DW, Bloomfield R, Walsh TS, Perkins GD, Menon D, Taylor BL, Rowan KM. Referral to an extracorporeal membrane oxygenation center and mortality among patients with severe 2009 influenza A(H1N1). JAMA. 2011 Oct 19;306(15):1659-68. doi: 10.1001/jama.2011.1471. Epub 2011 Oct 5. — View Citation

Roch A, Lepaul-Ercole R, Grisoli D, Bessereau J, Brissy O, Castanier M, Dizier S, Forel JM, Guervilly C, Gariboldi V, Collart F, Michelet P, Perrin G, Charrel R, Papazian L. Extracorporeal membrane oxygenation for severe influenza A (H1N1) acute respiratory distress syndrome: a prospective observational comparative study. Intensive Care Med. 2010 Nov;36(11):1899-905. doi: 10.1007/s00134-010-2021-3. Epub 2010 Aug 19. — View Citation

Villar J, Blanco J, Añón JM, Santos-Bouza A, Blanch L, Ambrós A, Gandía F, Carriedo D, Mosteiro F, Basaldúa S, Fernández RL, Kacmarek RM; ALIEN Network.. The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation. Intensive Care Med. 2011 Dec;37(12):1932-41. doi: 10.1007/s00134-011-2380-4. Epub 2011 Oct 14. Erratum in: Intensive Care Med. 2011 Dec;37(12):1942. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic changes in parameters of cardiac output		Within the first 6 hours after ICU admission
Primary	Hemodynamic changes in parameters of pulmonary artery pressure		Within the first 6 hours after ICU admission
Primary	Hemodynamic changes in parameters of left atrial pressures		Within the first 6 hours after ICU admission
Primary	Hemodynamic changes in volumetric parameters		Within the first 6 hours after ICU admission
Secondary	ICU length of stay		Within 28 days after ICU admission
Secondary	Time of ventilator		Within 28 days after ICU admission
Secondary	Necessity of ECMO support		Within 28 days after ICU admission
Secondary	Hospital length of stay		Within 28 days after ICU admission
Secondary	28-day mortality		Within 28 days after ICU admission