Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation
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Purpose
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.
| Condition |
|---|
|
Respiratory Distress Syndrome, Adult |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of Extravascular Lung Water and Hemodynamics Changes in Patients Treated by High Frequency Oscillation-ventilation for Refractory ARDS |
- Indexed Extra Vascular Lung Water (EVLWI) changes under HFO ventilation [ Time Frame: 3-day period after HFO-V ] [ Designated as safety issue: No ]
- Hemodynamics changes under HFO ventilation [ Time Frame: 3-day period after HFO-V ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | September 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
All ARDS patients will be treated according to a strictly defined protocol. Each patient will receive a standardised sedation with sufentanil, midazolam and atracurium. Tidal volume was adjusted on 6ml/kg of ideal body weight based on the height of each patient. Positive End Expiratory Pressure (PEEP) will be settled at the highest possible level (from 5 to 18cmH2O) without exceeding a plateau pressure below 30cmH2O. The oxygenation goal will a pulse oximeter saturation above 88%. Ventilation parameters will be adapted to the results of arterial blood gas samples realised 3 times a day.
Refractory patients will be defined by a PaO2/FiO2 ratio below 120 and will be eligible for "rescue techniques" like HFOV, prone position, nitrous oxide, Extra Corporeal Membrane Oxygenation (ECMO). Clinician choice for each technique will be unguided but if any rescue technique will be used prior to HFOV, patient will be not eligible for the study. All the patients will be monitored by a transpulmonary PiCCO technique. In every case, a femoral artery catheter (20cm, 5 French Pulsiocath, Pulsion Medical System) will be used for recording pressure and thermodilution signals via the PiCCOplus device V6.0 (Pulsion Medical System, Munich, Germany) using a venous central catheter.
Patients meeting the inclusion criteria after 12h of standardised ventilation will be placed under HFO-V and closely monitored by arterial blood gas sample, PiCCO-derived measurements and transthoracic echocardiography (primary and secondary outcome measures detailed later on).
HFOV failure will be defined by PaO2/FiO2<70 or hypercapnia > 55mmHg after optimisation of the HFO-V settings. In case of HFO-V failure, nitrous oxide will be used in first place as a complementary technique. In case of inefficacy, the investigators would switch to any other technique, causing the exclusion of the protocol.
HFOV weaning technique is also standardised : FiO2 will be lowered gradually 10 percents by 10 percents until 40% is reached. Then, the mean pressure will follow the same gradual lowering (2cmH2O by 2cmH2O until 24cmH2O). Once these two thresholds are reached, a HFOV weaning attempt will be realised with standard ventilation.
The investigators will also report any therapeutics that may influence hemodynamic measurements such as fluid challenge, diuretics, norepinephrine and sedation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Refractory Acute Respiratory Distress Syndrome (ARDS) patients admitted to the Intensive Care Unit of Saint-Denis hospital (REUNION ISLAND)
Inclusion Criteria:
- At least 18 years old
- Admission in ICU
- Transpulmonary PiCCO-technique monitoring
- Refractory ARDS (ratio PaO2/FiO2 < 120) after 12 hours of protective mechanical ventilation with maximal PEEP recruitment (inclusion is possible before this 12hours delay if the patient's status is worsening under optimised ventilation parameters AND plateau pressure above 30cm H2O OR saturation <88%)
- Choice of HFO-V as ventilation rescue technique
- Hemodynamic stability at plugging (after fluid challenge or norepinephrine if necessary)
Exclusion Criteria:
- Arteritis, hemostasis disorder
- Pneumothorax,
- Acute cardiac failure indicating a ECLS
- Previous use of other rescue techniques (Nitrous oxide, prone ventilation, ECMO)
Contacts and Locations| France | |
| Réanimation polyvalente, University Hospital Reunion Island - Felix Guyon Site | |
| Saint Denis de La Réunion, France, 97405 | |
| Principal Investigator: | Julien Jabot, MD | University Hospital Reunion Island - Felix Guyon Site |
More Information
Publications:
| Responsible Party: | Centre Hospitalier Universitaire de la Réunion ( Centre Hospitalier Felix Guyon ) |
| ClinicalTrials.gov Identifier: | NCT01167621 History of Changes |
| Other Study ID Numbers: | 2010/CHR/01 |
| Study First Received: | July 21, 2010 |
| Last Updated: | October 23, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Centre Hospitalier Universitaire de la Réunion:
|
Refractory Acute Respiratory Distress Syndrome Indexed Extra-vascular Lung Water HFO-ventilation |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on May 16, 2013