Acute Respiratory FailurePhase 4NCT00600639
Non-Invasive Mechanical Ventilation in Elderly Patients
A Phase 4 study testing Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option, standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed and standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed in people with Acute Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option, standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed and standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Dec 2007
- Phase
- Phase 4
- 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 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age higher 75 years old
- Hypercapnic acute respiratory failure (PaCO2 greater 50 mmHg and pH lower than 7.35)
- Respiratory rate (RR) higher 25 bpm after 12 hours of standard medical therapy.
Who cannot join
- Respiratory failure due to pulmonary oedema
- Kelly's score equal or higher than 4
- Cardio-respiratory arrest
- Systolic arterial blood pressure greater than 90 mmHg or severe arrhythmia
- Recent facial, oesophageal and gastric surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Scientifico di Pavia Fondazione Salvatore Maugeri
Pavia, Pavia, 27100
About this study
Official title: Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years.
A multicentric, randomized-controlled trial conduced in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
Read the detailed description
Non-invasive mechanical ventilation (NIMV) has been successfully used in Hypercapnic Acute Respiratory Failure (HARF) since endotracheal intubation (ETI) and invasive ventilation are associated to high morbidity and mortality rate.
because of the lack of beds in most Intensive Care Units (ICUs) and the high mortality and cost associated with the increased of age, the "Elderly" patients affected by ARF due to chronic diseases are not always considered for ETI.
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years (see tab1).
Authors MEAN AGE
(yrs) TYPE of STUDY
Bott <80 COPD NIV vs Medical Therapy
Brochard71±9 COPD NIV vs Medical Therapy
Kramer 66±7 COPD NIV vs Medical Therapy
Andeev 63±4 COPD NIV vs Medical Therapy
Barbe 70±2 COPD NIV vs Medical Therapy
Bardi 68±8 COPD NIV vs Medical Therapy
Plant 69±8 COPD NIV vs Medical Therapy
Thys 71±8 COPD NIV vs sham NIV
Nava 68±8 COPD NIV in weaning
Girault 63±14 NIV in weaning
Ferrer 70±7 NIV in weaning
Hill 71±3 COPD PAV vs PSV
Confalonieri 66±14 PNEUMONIA NIV vs Medical Therapy
Martin 64±17 Miscellaneous NIV vs Medical Therapy
Conti 72±7 COPD NIV vs EI
A multicentric, randomized-controlled trial conducted in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
- Conditions
- Acute Respiratory Failure
- Being tested
- Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option, standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed, standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
- Keywords
- old patients, NIV, Intubation, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV optionDevice
Also called BiPAP Vision or any other ICU ventilators with NIV option
A mode of ventilation that does not require the insertion of the endotracheal tube, since the support is delivered throgh a full face or nasal mask
standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as neededDrug
Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed
standard medical therapy that includes salbutamol, prednisolone and antibiotics as neededDrug
oxygen plus medical therapy for ARF
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option Receives: Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option; Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed |
| 2 | Active comparator | standard therapy + oxygen Receives: Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate
Measured: 3 months
Secondary outcomes (1)
Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Villa Gaiato, Modena, Ospedale Regionale di Locarno
- Investigators
- Stefano Nava, Principal investigator, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600639
- Sponsor's protocol ID
- FSM2004-78
- Other IDs
- 2004-78
- Status last verified
- Jan 2008
- First submitted
- 14 Jan 2008
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00600639
- Acronym / sponsor ID
- FSM2004-78
- Conditions
- Acute Respiratory Failure
- Keywords
- old patients, NIV, Intubation, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 82 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Villa Gaiato, Modena, Ospedale Regionale di Locarno
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Jan 2008 (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 efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years.
A multicentric, randomized-controlled trial conduced in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
Detailed description
Non-invasive mechanical ventilation (NIMV) has been successfully used in Hypercapnic Acute Respiratory Failure (HARF) since endotracheal intubation (ETI) and invasive ventilation are associated to high morbidity and mortality rate.
because of the lack of beds in most Intensive Care Units (ICUs) and the high mortality and cost associated with the increased of age, the "Elderly" patients affected by ARF due to chronic diseases are not always considered for ETI.
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years (see tab1).
Authors MEAN AGE
(yrs) TYPE of STUDY
Bott <80 COPD NIV vs Medical Therapy
Brochard71±9 COPD NIV vs Medical Therapy
Kramer 66±7 COPD NIV vs Medical Therapy
Andeev 63±4 COPD NIV vs Medical Therapy
Barbe 70±2 COPD NIV vs Medical Therapy
Bardi 68±8 COPD NIV vs Medical Therapy
Plant 69±8 COPD NIV vs Medical Therapy
Thys 71±8 COPD NIV vs sham NIV
Nava 68±8 COPD NIV in weaning
Girault 63±14 NIV in weaning
Ferrer 70±7 NIV in weaning
Hill 71±3 COPD PAV vs PSV
Confalonieri 66±14 PNEUMONIA NIV vs Medical Therapy
Martin 64±17 Miscellaneous NIV vs Medical Therapy
Conti 72±7 COPD NIV vs EI
A multicentric, randomized-controlled trial conducted in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option, Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needednon-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option |
| 2 | Active comparator | Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as neededstandard therapy + oxygen |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age higher 75 years old
- Hypercapnic acute respiratory failure (PaCO2 greater 50 mmHg and pH lower than 7.35)
- Respiratory rate (RR) higher 25 bpm after 12 hours of standard medical therapy.
Key exclusion criteria (5 listed)
- Respiratory failure due to pulmonary oedema
- Kelly's score equal or higher than 4
- Cardio-respiratory arrest
- Systolic arterial blood pressure greater than 90 mmHg or severe arrhythmia
- Recent facial, oesophageal and gastric surgery
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 |
|---|---|---|
| Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV optionAlso: BiPAP Vision or any other ICU ventilators with NIV optionA mode of ventilation that does not require the insertion of the endotracheal tube, since the support is delivered throgh a full face or nasal mask | Device | 1 |
| standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as neededStandard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed | Drug | 1 |
| standard medical therapy that includes salbutamol, prednisolone and antibiotics as neededoxygen plus medical therapy for ARF | Drug | 2 |
Primary outcome
Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate
Time frame: 3 months
1 secondary outcome
Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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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.
Stefano Nava principal investigator
Fondazione Salvatore Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option, standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed and standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed in people with Acute Respiratory Failure, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2012.