ARF Secondary to COPD ExacerbationNCT00375154
HERMES STUDY: Study on the Feasibility and Efficiency of Noninvasive Positive-Pressure Ventilation (NPPV) in Prehospital Care
A study testing Noninvasive Positive-Pressure Ventilation (NPPV) in people with ARF Secondary to COPD Exacerbation and ARF Secondary to Cardiogenic Acute Pulmonary Oedema, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 8 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARF Secondary to COPD Exacerbation, ARF Secondary to Cardiogenic Acute Pulmonary Oedema
- What is being tested?
- Noninvasive Positive-Pressure Ventilation (NPPV)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesBelgium
- Study dates
- Aug 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Clinical suspicion of pulmonary embolism.
- Retrosternal pain suggestive of a myocardial ischemia
- If the investigators are not available.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
Emergency Department; Cliniques Universitaires Saint-Luc
Brussels, B1200
CHU Brugman-Schaerbeek
Brussels
Hôpital de Dinant
Dinant
Cliniques Notre Dame de Gosselies
Gosselies
Citadelle CHR Liège
Liège
CHR Namur
Namur
CHR de Tournai
Tournai
Cliniques Universitaires de Mont-Godinne ; Université Catholique de Louvain
Yvoir
About this study
Official title: Noninvasive Positive-pressure Ventilation (NPPV) for Acute Respiratory Failure in Out-of-hospital Patients: a Multicenter, Prospective, Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Noninvasive Positive-Pressure Ventilation (NPPV)
- Keywords
- Acute respiratory failure, Prehospital care, Noninvasive ventilation, Emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Positive-Pressure Ventilation (NPPV)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the number of in each arm of the study failing at the time of admission in emergency department.
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startAug 2006
Why it stopped: major difficulties in training investigators in other centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ARF Secondary to COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Frederic Thys,MD,PhD
- Investigators
- Frederic C Thys, MD,PhD, Study chair, Emergency Department; Cliniques Universitaires Saint-Luc; Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375154
- Sponsor's protocol ID
- URGPROT1
- Status last verified
- Jul 2011
- First submitted
- 11 Sep 2006
- Last updated
- 20 Jul 2011
- Results posted
- No
Publications
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.
PubMed 12358327Thys 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.
PubMed 10622384Vanpee 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.
PubMed 12394617Craven 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.
PubMed 11044006
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Positive-pressure Ventilation (NPPV) for Acute Respiratory Failure in Out-of-hospital Patients: a Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00375154
- Acronym / sponsor ID
- URGPROT1
- Keywords
- Acute respiratory failure, Prehospital care, Noninvasive ventilation, Emergency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: major difficulties in training investigators in other centers
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Frederic Thys,MD,PhD
- Study start
- Aug 2006
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive Positive-Pressure Ventilation (NPPV) | Device | – |
Primary outcome
Difference in the number of in each arm of the study failing at the time of admission in emergency department.
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Background: PubMed 12358327Thys 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.
- Background: PubMed 10622384Thys 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.
- Background: PubMed 12394617Vanpee 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.
- Background: PubMed 11044006Craven 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic C Thys, MD,PhD study chair
Emergency Department; Cliniques Universitaires Saint-Luc; Université Catholique de Louvain
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Positive-Pressure Ventilation (NPPV) in people with ARF Secondary to COPD Exacerbation and ARF Secondary to Cardiogenic Acute Pulmonary Oedema, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the number of in each arm of the study failing at the time of admission in emergency department.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375154, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.