Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation

NCT01167621 | Completed

• 1 other identifier: 2010/CHR/01
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The study is intended to evaluate the hemodynamic and the indexed extrapulmonary lung water (ELWI) changes in patients treated by high frequency oscillation-ventilation (HFO-V) for refractory acute respiratory distress syndrome (ARDS). HFO-V may be used as rescue treatment in refractory ARDS but its hemodynamic impact is discussed. Moreover, as Extra Vascular Lung Water (a transpulmonary thermodilution parameter) was proven to be an independent mortality factor in ICU-patients, the investigators decided to monitor it in all ARDS patients who ended up needing HFO-V, from HFO-V plugging under 72 hours of this type of ventilation. All ARDS patients underwent high Positive End Expiratory Pressure (PEEP) with "protective ventilation" and those who remained below a PaO2/FiO2 ratio of 120 after 24h will be considered as "refractory ARDS patients" and, therefore eligible. They will be monitored by the transpulmonary thermodilution PiCCO technique (Pulsion Medical System. Munich, Germany) and placed under HFO-V. Both transpulmonary thermodilution measurements (ELWI , Cardiac Output, Global End-diastolic Volume) and standard transthoracic echocardiographic measurements (Ejection Fraction, End-diastolic Right and Left Ventricular Area, preload indexes) were be performed from HFO-V plugging to Day 3. The investigators suggest that ELWI will be correlated to HFO-V responsiveness and that cardiac output will not change at the HFO-V plugging, regardless of preload indexes variation. Inclusion will be proceeded over a 2 year period and, according to the population, the investigators expect about 50 eligible patients.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Refractory Acute Respiratory Distress Syndrome; Indexed Extra-vascular Lung Water; HFO-ventilation

Outcome Measures

Primary Outcomes (1)

• Indexed Extra Vascular Lung Water (EVLWI) changes under HFO ventilation

  3-day period after HFO-V

Secondary Outcomes (1)

• Hemodynamics changes under HFO ventilation

  3-day period after HFO-V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Refractory Acute Respiratory Distress Syndrome (ARDS) patients admitted to the Intensive Care Unit of Saint-Denis hospital (REUNION ISLAND)

You may qualify if:

• At least 18 years old
• Admission in ICU
• Transpulmonary PiCCO-technique monitoring
• Choice of HFO-V as ventilation rescue technique
• Hemodynamic stability at plugging (after fluid challenge or norepinephrine if necessary)

You may not qualify if:

• Arteritis, hemostasis disorder
• Pneumothorax,
• Acute cardiac failure indicating a ECLS
• Previous use of other rescue techniques (Nitrous oxide, prone ventilation, ECMO)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Réanimation polyvalente, University Hospital Reunion Island - Felix Guyon Site

Saint Denis de La Réunion, 97405, France

Location

Related Publications (10)

• Simma B, Fritz M, Fink C, Hammerer I. Conventional ventilation versus high-frequency oscillation: hemodynamic effects in newborn babies. Crit Care Med. 2000 Jan;28(1):227-31. doi: 10.1097/00003246-200001000-00038.

  PMID: 10667528 BACKGROUND

• Traverse JH, Korvenranta H, Adams EM, Goldthwait DA, Carlo WA. Cardiovascular effects of high-frequency oscillatory and jet ventilation. Chest. 1989 Dec;96(6):1400-4. doi: 10.1378/chest.96.6.1400.

  PMID: 2684557 BACKGROUND

• Arnold JH, Truog RD, Thompson JE, Fackler JC. High-frequency oscillatory ventilation in pediatric respiratory failure. Crit Care Med. 1993 Feb;21(2):272-8. doi: 10.1097/00003246-199302000-00021.

  PMID: 8428481 BACKGROUND

• Zobel G, Dacar D, Rodl S. Hemodynamic effects of different modes of mechanical ventilation in acute cardiac and pulmonary failure: an experimental study. Crit Care Med. 1994 Oct;22(10):1624-30.

  PMID: 7924375 BACKGROUND

• Jabot J, Teboul JL, Richard C, Monnet X. Passive leg raising for predicting fluid responsiveness: importance of the postural change. Intensive Care Med. 2009 Jan;35(1):85-90. doi: 10.1007/s00134-008-1293-3. Epub 2008 Sep 16.

  PMID: 18795254 BACKGROUND

• Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.

  PMID: 19237902 BACKGROUND

• Sakka SG, Klein M, Reinhart K, Meier-Hellmann A. Prognostic value of extravascular lung water in critically ill patients. Chest. 2002 Dec;122(6):2080-6. doi: 10.1378/chest.122.6.2080.

  PMID: 12475851 BACKGROUND

• Craig TR, Duffy MJ, Shyamsundar M, McDowell C, McLaughlin B, Elborn JS, McAuley DF. Extravascular lung water indexed to predicted body weight is a novel predictor of intensive care unit mortality in patients with acute lung injury. Crit Care Med. 2010 Jan;38(1):114-20. doi: 10.1097/CCM.0b013e3181b43050.

  PMID: 19789451 BACKGROUND

• Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.

  PMID: 18270353 BACKGROUND

• Ursulet L, Roussiaux A, Belcour D, Ferdynus C, Gauzere BA, Vandroux D, Jabot J. Right over left ventricular end-diastolic area relevance to predict hemodynamic intolerance of high-frequency oscillatory ventilation in patients with severe ARDS. Ann Intensive Care. 2015 Dec;5(1):25. doi: 10.1186/s13613-015-0068-6. Epub 2015 Sep 17.

  PMID: 26380993 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Julien Jabot, MD

  University Hospital Reunion Island - Felix Guyon Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

FR (1)