Acute Respiratory Distress SyndromeNPPVNCT00644930
Non-Invasive Positive Pressure Ventilation and Adult Respiratory Distress Syndrome (ARDS)
A study testing the application of NPPV and invasive ventilation in people with Acute Respiratory Distress Syndrome, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Background and objective: To determine the efficacy of non-invasive positive pressure ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- the application of NPPV and invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2003to Dec 2007
- 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
None listed.
Who cannot join
- The need for urgent intubation.
- The need for frequent aspiration due to excessive secretions (more frequent than 15 min.).
- Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University, Medical Faculty,
Eskişehir, Merkez, 26040
About this study
Official title: The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study
Background and objective: To determine the efficacy of non-invasive positive pressure ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.
Read the detailed description
Methods: This study was performed in the respiratory intensive care unit (ICU) at a university hospital. 20 patients who achieved the diagnostic criteria for ARDS were included. The patients were prospectively allocated into two groups: a standard therapy group and a NPPV group. Invasive mechanical ventilation indications had been determined before the study. Invasive ventilation was applied to those who in need of intubation, while those given intubation received a standard medical treatment.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- the application of NPPV, invasive ventilation
- Keywords
- ARDS,, noninvasive ventilation,, intubation,, mortality,, intensive care
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the application of NPPVDevice
Also called NPPV group
ARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated. BIPAP Vision machine (Respironics, PA, USA) were used for NPPV.
invasive ventilationDevice
Also called Standard therapy group
Standard therapy group (invasive ventilation). Patients in need of endotracheal intubation were mechanically ventilated with Amadeus (Hamilton, Via Nova, Switzerland) and Esprit (Respironics, PA, USA) ventilators in the assist-control or synchronized intermittent mandatory ventilation (SIMV) mode.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated. Receives: Device: the application of NPPV |
| 2 | Active comparator | Patients in the standard therapy group without indications for urgent intubation were only given standard medical therapy (such as oxygen, antibiotics, and bronchodilators), and IMV through an endotracheal tube was applied when intubation criteria were met. Receives: Device: invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
Measured: 48 hours
Secondary outcomes (1)
Hospital mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startAug 2003
- Primary completionSep 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Investigators
- Irfan Ucgun, Ass Prof Dr, Study chair, Eskisehir Osmangazi University, Medical Faculty, Department of Chest Dis.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644930
- Sponsor's protocol ID
- ISRCTN73824458
- Other IDs
- ISRCTN73824458
- Acronym
- NPPV
- Status last verified
- Mar 2008
- First submitted
- 14 Mar 2008
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rana S, Jenad H, Gay PC, Buck CF, Hubmayr RD, Gajic O. Failure of non-invasive ventilation in patients with acute lung injury: observational cohort study. Crit Care. 2006;10(3):R79. doi: 10.1186/cc4923. Epub 2006 May 12.
PubMed 16696863Liesching T, Kwok H, Hill NS. Acute applications of noninvasive positive pressure ventilation. Chest. 2003 Aug;124(2):699-713. doi: 10.1378/chest.124.2.699.
PubMed 12907562Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, Meduri GU. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007 Jan;35(1):18-25. doi: 10.1097/01.CCM.0000251821.44259.F3.
PubMed 17133177
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT00644930
- Acronym / sponsor ID
- NPPV / ISRCTN73824458
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS,, noninvasive ventilation,, intubation,, mortality,, intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Mar 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.
Background and objective: To determine the efficacy of non-invasive positive pressure ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.
Detailed description
Methods: This study was performed in the respiratory intensive care unit (ICU) at a university hospital. 20 patients who achieved the diagnostic criteria for ARDS were included. The patients were prospectively allocated into two groups: a standard therapy group and a NPPV group. Invasive mechanical ventilation indications had been determined before the study. Invasive ventilation was applied to those who in need of intubation, while those given intubation received a standard medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: the application of NPPVARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated. |
| 2 | Active comparator | Device: invasive ventilationPatients in the standard therapy group without indications for urgent intubation were only given standard medical therapy (such as oxygen, antibiotics, and bronchodilators), and IMV through an endotracheal tube was applied when intubation criteria were met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- The need for urgent intubation.
- The need for frequent aspiration due to excessive secretions (more frequent than 15 min.).
- Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.
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 |
|---|---|---|
| the application of NPPVAlso: NPPV groupARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated. BIPAP Vision machine (Respironics, PA, USA) were used for NPPV. | Device | 1 |
| invasive ventilationAlso: Standard therapy groupStandard therapy group (invasive ventilation). Patients in need of endotracheal intubation were mechanically ventilated with Amadeus (Hamilton, Via Nova, Switzerland) and Esprit (Respironics, PA, USA) ventilators in the assist-control or synchronized intermittent mandatory ventilation (SIMV) mode. | Device | 2 |
Primary outcome
Intubation rate
Time frame: 48 hours
1 secondary outcome
Hospital mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
- Results publication: PubMed 16696863Rana S, Jenad H, Gay PC, Buck CF, Hubmayr RD, Gajic O. Failure of non-invasive ventilation in patients with acute lung injury: observational cohort study. Crit Care. 2006;10(3):R79. doi: 10.1186/cc4923. Epub 2006 May 12.
- Results publication: PubMed 12907562Liesching T, Kwok H, Hill NS. Acute applications of noninvasive positive pressure ventilation. Chest. 2003 Aug;124(2):699-713. doi: 10.1378/chest.124.2.699.
- Results publication: PubMed 17133177Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, Meduri GU. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007 Jan;35(1):18-25. doi: 10.1097/01.CCM.0000251821.44259.F3.
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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.
Irfan Ucgun, Ass Prof Dr study chair
Eskisehir Osmangazi University, Medical Faculty, Department of Chest Dis.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the application of NPPV and invasive ventilation in people with Acute Respiratory Distress Syndrome, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 0 inclusion and 3 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: finished, as of the sponsor's last update on 27 Mar 2008. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intubation rate (time frame: 48 hours). 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 NCT00644930, which also lists 3 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 27 Mar 2008.