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

This study has been withdrawn prior to enrollment.
(major difficulties in training investigators in other centers)
Sponsor:
Collaborator:
Frederic Thys,MD,PhD
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00375154
First received: September 11, 2006
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
ARF Secondary to COPD Exacerbation
ARF Secondary to Cardiogenic Acute Pulmonary Oedema
Device: Noninvasive Positive-Pressure Ventilation (NPPV)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Noninvasive Positive-pressure Ventilation (NPPV) for Acute Respiratory Failure in Out-of-hospital Patients: a Multicenter, Prospective, Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Difference in the number of in each arm of the study failing at the time of admission in emergency department.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: August 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375154

Locations
Belgium
CHU Brugman-Schaerbeek
Brussels, Belgium
Emergency Department; Cliniques Universitaires Saint-Luc
Brussels, Belgium, B1200
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, Belgium
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Frederic Thys,MD,PhD
Investigators
Study Chair: Frederic C Thys, MD,PhD Emergency Department; Cliniques Universitaires Saint-Luc; Université Catholique de Louvain
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00375154     History of Changes
Other Study ID Numbers: URGPROT1
Study First Received: September 11, 2006
Last Updated: July 19, 2011
Health Authority: Belgium: Université Catholique de Louvain
Cliniques universitaires Saint-Luc: Brussels

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Acute respiratory failure
Prehospital care
Noninvasive ventilation
Emergency

Additional relevant MeSH terms:
Neoplasm Metastasis
Pulmonary Edema
Respiratory Insufficiency
Lung Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014