Invasive Mechanical Ventilation Clinical Trial
— ENCODEOfficial title:
Hemodynamic and Cardiac Effects of Individualized PEEP Titration Using Esophageal Pressure Measurements in ARDS Patients
Verified date | April 2017 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02877524 -
Trial to Study Intubation Rates of Non-invasive Ventilation Using Pressure Support Ventilation (PSV) Versus Adaptive Support Ventilation (ASV) Mode in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT04199273 -
Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking
|
N/A | |
Completed |
NCT03955874 -
Mechanical Ventilation Discontinuation Practices
|
||
Recruiting |
NCT06404294 -
The External Diaphragm Pacemaker Assisted Extubation in Premature Infants With Invasive Mechanical Ventilation
|
N/A | |
Not yet recruiting |
NCT06288724 -
MOdifiable facTors to Improve VentilAtion ThErapy in ICU
|
||
Not yet recruiting |
NCT06217406 -
Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes (PTH2)
|
N/A | |
Terminated |
NCT03460015 -
Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation
|
N/A | |
Completed |
NCT04383730 -
Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)
|
||
Recruiting |
NCT05056961 -
Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.
|
N/A | |
Completed |
NCT02380547 -
Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation
|
||
Terminated |
NCT04222569 -
Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation
|
N/A | |
Recruiting |
NCT05880953 -
Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator
|
N/A | |
Recruiting |
NCT05668637 -
Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support
|
||
Not yet recruiting |
NCT06261996 -
Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.
|
N/A | |
Completed |
NCT02877498 -
A Study to Compare Adaptive Support Ventilation vs. Volume Controlled Ventilation for Management of Respiratory Failure in Patients With Neuroparalytic Snake Envenomation
|
N/A | |
Recruiting |
NCT05081973 -
A Model for Predicting Extubation Success in Premature Babies
|