Community Acquired Pneumonia.NIMV AND SCAPNCT00523497
Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia
A study testing Non invasive mechanical ventilation in people with Community Acquired Pneumonia. and Acute Hypoxemic Respiratory Failure, run by Hospital Privado del Sur at 1 site in Argentina.
Trial summary
The purpose of this study is to determine whether the noninvasive ventilation is more effective in the treatment of severe comunity acquired pneumonia in comparison with the conventional mechanical ventilation with orotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Community Acquired Pneumonia., Acute Hypoxemic Respiratory Failure
- What is being tested?
- Non invasive mechanical ventilation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteArgentina
- Study dates
- Start not givento 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 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- The criteria for the diagnosis of SCAP included:
- Blood systolic pressure lower than 90 mmHg or blood diastolic pressure lower than 60 mmHg
- RR higher than 30 breaths per minute
- PaO2/FiO2 lower than 250 while breathing through a Venturi mask with a 50% inspired oxygen fraction (FiO2)
- Bilateral or multiple lobar infiltrations evidenced by thorax X-ray, and
- Use of vasopressor drugs
Who cannot join
- COPD
- Asthma
- Acute cardiogenic pulmonary edema
- Severe haemodynamic instability (arterial systolic pressure lower than 70 mmHg) or requirements of vasoactive drugs
- Glasgow score equal to or lower than 9 or requiring OTI for airway protection or for recent pulmonary resucitation
- Antecedents of respiratory failure resulting from neuromuscular pathology
Show all 9Show fewer
- Failure of two or more organs
- Facial deformities; and
- Recent facial, aesophagic and gastric surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Mechanical Ventilation in Severe Community-Acquired Pneumonia and Acute Hypoxemic Respiratory Failure. A Prospective, Randomized and Controlled Study
The purpose of this study is to determine whether the noninvasive ventilation is more effective in the treatment of severe comunity acquired pneumonia in comparison with the conventional mechanical ventilation with orotracheal intubation.
- Being tested
- Non invasive mechanical ventilation
- Keywords
- Severe community-acquired pneumonia, Noninvasive mechanical ventilation, Acute hypoxemic respiratory failure.
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive mechanical ventilationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this study was to compare the effects of NIMV on mortality rate and length of stay at the ICU with the effects of CMV
Measured: 3 years
Secondary outcomes (1)
The secondary aims were to evaluate the incidence and the complications of OTI as well as to compare the improvements in the gas exchange.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
Why it stopped: Interim analysis of the present study showed a significant decrease in mortality rate (p= 0.04) as well as in the number of days at the ICU p=0.0002.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia.Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hospital Privado del Sur
- Sponsor type
- University, hospital or other
- Investigators
- S. A Lasdica, Study Principal Investigator, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523497
- Sponsor's protocol ID
- NIV67-07
- Acronym
- NIMV AND SCAP
- Status last verified
- Aug 2007
- First submitted
- 30 Aug 2007
- Last updated
- 31 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Mechanical Ventilation in Severe Community-Acquired Pneumonia and Acute Hypoxemic Respiratory Failure. A Prospective, Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT00523497
- Acronym / sponsor ID
- NIMV AND SCAP / NIV67-07
- Keywords
- Severe community-acquired pneumonia, Noninvasive mechanical ventilation, Acute hypoxemic respiratory failure.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis of the present study showed a significant decrease in mortality rate (p= 0.04) as well as in the number of days at the ICU p=0.0002.
- Lead sponsor
- Hospital Privado del SurUniversity, hospital or other
- First posted
- 31 Aug 2007 (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 to determine whether the noninvasive ventilation is more effective in the treatment of severe comunity acquired pneumonia in comparison with the conventional mechanical ventilation with orotracheal intubation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Blood systolic pressure lower than 90 mmHg or blood diastolic pressure lower than 60 mmHg
- RR higher than 30 breaths per minute
- PaO2/FiO2 lower than 250 while breathing through a Venturi mask with a 50% inspired oxygen fraction (FiO2)
- Bilateral or multiple lobar infiltrations evidenced by thorax X-ray, and
- Use of vasopressor drugs
Key exclusion criteria (9 listed)
- COPD
- Asthma
- Acute cardiogenic pulmonary edema
- Severe haemodynamic instability (arterial systolic pressure lower than 70 mmHg) or requirements of vasoactive drugs
- Glasgow score equal to or lower than 9 or requiring OTI for airway protection or for recent pulmonary resucitation
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 | Device | – |
Primary outcome
The primary aim of this study was to compare the effects of NIMV on mortality rate and length of stay at the ICU with the effects of CMV
Time frame: 3 years
1 secondary outcome
The secondary aims were to evaluate the incidence and the complications of OTI as well as to compare the improvements in the gas exchange.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Interim analysis of the present study showed a significant decrease in mortality rate (p= 0.04) as well as in the number of days at the ICU p=0.0002.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2007.
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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.
S. A Lasdica, Study Principal Investigator principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive mechanical ventilation in people with Community Acquired Pneumonia. and Acute Hypoxemic Respiratory Failure, run by Hospital Privado del Sur at 1 site in Argentina.
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 6 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: stopped early, as of the sponsor's last update on 31 Aug 2007. 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 Argentina. 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 stopped early (reason given: Interim analysis of the present study showed a significant decrease in mortality rate (p= 0.04) as well as in the number of days at the ICU p=0.0002.). 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?
The primary aim of this study was to compare the effects of NIMV on mortality rate and length of stay at the ICU with the effects of CMV (time frame: 3 years). 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 31 Aug 2007; AzTrials last refreshed its copy on 6 Nov 2026.