HERMES STUDY: Study on the Feasibility and Efficiency of Noninvasive Positive-Pressure Ventilation (NPPV) in Prehospital Care

ARF Secondary to Cardiogenic Acute Pulmonary Oedema Clinical Trial

Official title:

Noninvasive Positive-pressure Ventilation (NPPV) for Acute Respiratory Failure in Out-of-hospital Patients: a Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00375154
• Other study ID #: URGPROT1
• Status: Withdrawn
• Phase: N/A
• First received: September 11, 2006
• Last updated: July 19, 2011
• Start date: August 2006

Study information

• Verified date: July 2011
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Université Catholique de LouvainCliniques universitaires Saint-Luc: Brussels
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ARF Secondary to Cardiogenic Acute Pulmonary Oedema
• ARF Secondary to COPD Exacerbation
• Neoplasm Metastasis
• Pulmonary Edema

Intervention

Device:
• Noninvasive Positive-Pressure Ventilation (NPPV)

Locations

Country	Name	City	State
Belgium	CHU Brugman-Schaerbeek	Brussels
Belgium	Emergency Department; Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hôpital de Dinant	Dinant
Belgium	Cliniques Notre Dame de Gosselies	Gosselies
Belgium	Citadelle CHR Liège	Liege
Belgium	CHR Namur	Namur
Belgium	CHR de Tournai	Tournai
Belgium	Cliniques Universitaires de Mont-Godinne ; Université Catholique de Louvain	Yvoir

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Frederic Thys,MD,PhD

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the number of in each arm of the study failing at the time of admission in emergency department.
Secondary	Effects of the ventilatory mode on the clinical and arterial-blood gas parameters
Secondary	Hospital mortality
Secondary	Admission to the ICU, the length of ED stay, the length of ICU stay and the length of hospital stay