Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375154
Status:
WITHDRAWN
Last Update Posted:
2011-07-20
First Post:
2006-09-11
Brief Title:
HERMES STUDY Study on the Feasibility and Efficiency of Noninvasive Positive-Pressure Ventilation NPPV in Prehospital Care
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
Noninvasive Positive-pressure Ventilation NPPV for Acute Respiratory Failure in Out-of-hospital Patients a Multicenter Prospective Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
major difficulties in training investigators in other centers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None