HERMES STUDY: Study on the Feasibility and Efficiency of Noninvasive Positive-Pressure Ventilation (NPPV) in Prehospital Care
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|ClinicalTrials.gov Identifier: NCT00375154|
Recruitment Status : Withdrawn (major difficulties in training investigators in other centers)
First Posted : September 12, 2006
Last Update Posted : July 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|ARF Secondary to COPD Exacerbation ARF Secondary to Cardiogenic Acute Pulmonary Oedema||Device: Noninvasive Positive-Pressure Ventilation (NPPV)||Not Applicable|
Noninvasive positive-pressure ventilation (NPPV) is increasingly being used in the care of patients suffering acute respiratory failure. High-level evidence supports the use of NPPV in this setting. With selected patients, NPPV decreases the rate of intubation, mortality and nosocomial infections. NPPV obviates intubation in > 50 % of appropriately selected patients. Both nasal and oronasal interfaces have been successfully used to apply NPPV, but the oronasal (or facial) interface is often used for acute respiratory failure. Any ventilator and ventilator mode can be used to apply NPPV, but in practice, portable pressure ventilators and pressure-support mode are most commonly used.
In acute setting, this therapy must be applied as soon as possible after the onset of problem. With our research team, we have demonstrated that NPPV can be used with success in an emergency department. In our experience, when NPPV was early used, part of the patients improved rapidly and was could be admitted to a general ward. An interesting fact is that the time to improve clinical situation is short and we can postulated than NPPV application in emergency department may be used as a "clinical triage". We have also demonstrated that early application of bi-level NPPV to patients with acute respiratory failure due to acute exacerbation of COPD or APO leads to a rapid improvement in clinical status and blood gases that differs substantially from the evolution of similar patients treated with conventional medical therapy and a placebo NPPV device.
Currently, we have very few data on the real utility to use of NPPV in Out-of-Hospital patients with acute respiratory failure managed by medical team of pre-hospital care despite the fact that this approach decreased the delay of application of a efficient ventilator support. A prior study of Craven and coll. has demonstrated that NPPV helps relieve dyspnea in patients with suspected congestive heart failure.
We can postulate that a shorter delay between onset of symptomatology and application of NPPV increased the part of selected patient with good clinical outcome (intubation, need of intensive care).
Patients with COPD, APO with standard medical therapy + NPPV compared to patients with standard medical therapy alone in pre-hospital setting.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Noninvasive Positive-pressure Ventilation (NPPV) for Acute Respiratory Failure in Out-of-hospital Patients: a Multicenter, Prospective, Randomized Controlled Trial|
|Study Start Date :||August 2006|
- Difference in the number of in each arm of the study failing at the time of admission in emergency department.
- Effects of the ventilatory mode on the clinical and arterial-blood gas parameters
- Hospital mortality
- Admission to the ICU, the length of ED stay, the length of ICU stay and the length of hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375154
|Emergency Department; Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, B1200|
|Hôpital de Dinant|
|Cliniques Notre Dame de Gosselies|
|Citadelle CHR Liège|
|CHR de Tournai|
|Cliniques Universitaires de Mont-Godinne ; Université Catholique de Louvain|
|Study Chair:||Frederic C Thys, MD,PhD||Emergency Department; Cliniques Universitaires Saint-Luc; Université Catholique de Louvain|