Clinical trial NCT00375154: HERMES STUDY: Study on the Feasibility and Efficiency of Noninvasive Positive-Pressure Ventilation (NPPV) in Prehospital Care
Official title: Noninvasive Positive-pressure Ventilation (NPPV) for Acute Respiratory Failure in Out-of-hospital Patients: a Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: ARF Secondary to COPD Exacerbation
ARF Secondary to Cardiogenic Acute Pulmonary Oedema
Keywords: Acute respiratory failure
Prehospital care
Noninvasive ventilation
Emergency
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Frederic Thys,MD,PhD
First posted: 2006-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is determine if NPPV can be performed in a pre-hospital setting very early after onset of dyspnea with a similar benefit in need of intubation and mortality as in previous study in hospital context and if early NPPV intervention have a real, rather standard medical therapy, value, both on objectively measured parameters and on patient's clinical status.

Detailed description: 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).

Comparisons :

Patients with COPD, APO with standard medical therapy + NPPV compared to patients with standard medical therapy alone in pre-hospital setting.

Eligibility criteria: Inclusion Criteria:

* Out-of-hospital patients with acute respiratory failure
* only patients with COPD, APO are included.
* Patients are eligible into the study if the attending physician judged that the need of a mechanical ventilatory support is imminent.
* Patients not improving under usual treatment

Exclusion Criteria:

* An immediate indication for endotracheal intubation (respiratory and/or cardiac arrest).
* Major unrest.
* Hemodynamic instability despite a fluid challenge (500 ml of colloids).
* Facial or thoracic trauma.
* Lack of cooperation.
* Difficult adaptation of facial mask to patient's facial anatomy.
* Clinical suspicion of pulmonary embolism.
* Retrosternal pain suggestive of a myocardial ischemia
* If the investigators are not available.

Primary outcomes:
measure: Difference in the number of in each arm of the study failing at the time of admission in emergency department.
Secondary outcomes:
measure: Effects of the ventilatory mode on the clinical and arterial-blood gas parameters
measure: Hospital mortality
measure: Admission to the ICU, the length of ED stay, the length of ICU stay and the length of hospital stay
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Emergency Department; Cliniques Universitaires Saint-Luc
city: Brussels
country: Belgium
facility: CHU Brugman-Schaerbeek
city: Dinant
country: Belgium
facility: Hôpital de Dinant
city: Gosselies
country: Belgium
facility: Cliniques Notre Dame de Gosselies
city: Liege
country: Belgium
facility: Citadelle CHR Liège
city: Namur
country: Belgium
facility: CHR Namur
city: Tournai
country: Belgium
facility: CHR de Tournai
city: Yvoir
country: Belgium
facility: Cliniques Universitaires de Mont-Godinne ; Université Catholique de Louvain
Study officials:
affiliation: Emergency Department; Cliniques Universitaires Saint-Luc; Université Catholique de Louvain
name: Frederic C Thys, MD,PhD
role: STUDY_CHAIR
References:
citation: Thys F, Roeseler J, Reynaert M, Liistro G, Rodenstein DO. Noninvasive ventilation for acute respiratory failure: a prospective randomised placebo-controlled trial. Eur Respir J. 2002 Sep;20(3):545-55. doi: 10.1183/09031936.02.00287402.
citation: Thys F, Roeseler J, Delaere S, Palavecino L, El Gariani A, Marion E, Meert P, Danse E, D'Hoore W, Reynaert M. Two-level non-invasive positive pressure ventilation in the initial treatment of acute respiratory failure in an emergency department. Eur J Emerg Med. 1999 Sep;6(3):207-14.
citation: Vanpee D, Delaunois L, Lheureux P, Thys F, Sabbe M, Meulemans A, Stroobants J, Dorio V, Gillet JB. Survey of non-invasive ventilation for acute exacerbation of chronic obstructive pulmonary disease patients in emergency departments in Belgium. Eur J Emerg Med. 2002 Sep;9(3):217-24. doi: 10.1097/00063110-200209000-00003.
citation: Craven RA, Singletary N, Bosken L, Sewell E, Payne M, Lipsey R. Use of bilevel positive airway pressure in out-of-hospital patients. Acad Emerg Med. 2000 Sep;7(9):1065-8. doi: 10.1111/j.1553-2712.2000.tb02102.x.