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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion ( Centre Hospitalier Felix Guyon )
ClinicalTrials.gov Identifier:
NCT01167621
First received: July 21, 2010
Last updated: October 23, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de la Réunion:

Primary Outcome Measures:
  • Indexed Extra Vascular Lung Water (EVLWI) changes under HFO ventilation [ Time Frame: 3-day period after HFO-V ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167621

Locations
France
Réanimation polyvalente, University Hospital Reunion Island - Felix Guyon Site
Saint Denis de La Réunion, France, 97405
Sponsors and Collaborators
Centre Hospitalier Felix Guyon
Investigators
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 April 23, 2014