Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation
|ClinicalTrials.gov Identifier: NCT01167621|
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 29, 2015
|Condition or disease|
|Respiratory Distress Syndrome, Adult|
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.
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Official Title:||Assessment of Extravascular Lung Water and Hemodynamics Changes in Patients Treated by High Frequency Oscillation-ventilation for Refractory ARDS|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
- Indexed Extra Vascular Lung Water (EVLWI) changes under HFO ventilation [ Time Frame: 3-day period after HFO-V ]
- Hemodynamics changes under HFO ventilation [ Time Frame: 3-day period after HFO-V ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167621
|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|