Acute Respiratory FailurePhase 4NCT00925860
Non-Positive Pressure Ventilation in Hypoxemic Patients
A Phase 4 study testing non positive pressure mechanical ventilatory support in people with Acute Respiratory Failure, run by Hospital Provincial de Castellon at 1 site in Spain.
Trial summary
The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- non positive pressure mechanical ventilatory support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2001to Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dyspnea with respiratory rates higher than 35 p.m.
- pO2 < 65 mmHg
- paO2/FiO2 < 250
Who cannot join
- respiratory or cardiac arrest
- gastrointestinal bleeding
- hemodynamic instability
- face surgery
- upper airway obstruction
- inability for active cooperation
Show all 10Show fewer
- need for airway protection
- exacerbation of COPD
- decrease of conscious level
- acute pulmonary cardiogenic oedema
Trial locations and contacts
1 site in 1 country.
Spain1 site
Intensive Care Department - General Hospital
Castelló, CASTELLO, 12004
About this study
Official title: Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study
The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.
Read the detailed description
Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.
- Conditions
- Acute Respiratory Failure
- Being tested
- non positive pressure mechanical ventilatory support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non positive pressure mechanical ventilatory supportProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| non invasive ventilation approach | Experimental | pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation Receives: Procedure: non positive pressure mechanical ventilatory support |
| conventionally ventilated | No intervention | pure hypoxemic patients treated by conventional ventilatory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rates
Measured: patient hospital discharge
Secondary outcomes (3)
oxygenation improve
Measured: patient hospital discharge
diminishing of tracheal intubation incidence
Measured: patient hospital discharge
ICU and Post ICU hospital length of stay
Measured: patient hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2001
- Primary completionJun 2006
- Study completionJun 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Provincial de Castellon
- Sponsor type
- University, hospital or other
- Investigators
- Alberto Belenguer, MD, Principal investigator, INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925860
- Sponsor's protocol ID
- HGCS-2009-1
- Status last verified
- Jun 2009
- First submitted
- 19 Jun 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study
- ClinicalTrials.gov ID
- NCT00925860
- Acronym / sponsor ID
- HGCS-2009-1
- Conditions
- Acute Respiratory Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital Provincial de CastellonUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Jun 2009 (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 study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.
Detailed description
Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non invasive ventilation approach | Experimental | Procedure: non positive pressure mechanical ventilatory supportpure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation |
| conventionally ventilated | No intervention | –pure hypoxemic patients treated by conventional ventilatory support |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- dyspnea with respiratory rates higher than 35 p.m.
- pO2 < 65 mmHg
- paO2/FiO2 < 250
Key exclusion criteria (10 listed)
- respiratory or cardiac arrest
- gastrointestinal bleeding
- hemodynamic instability
- face surgery
- upper airway obstruction
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 positive pressure mechanical ventilatory support | Procedure or surgery | non invasive ventilation approach |
Primary outcome
mortality rates
Time frame: patient hospital discharge
3 secondary outcomes
oxygenation improve
Time frame: patient hospital discharge
diminishing of tracheal intubation incidence
Time frame: patient hospital discharge
ICU and Post ICU hospital length of stay
Time frame: patient hospital discharge
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 22 Jun 2009.
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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.
Alberto Belenguer, MD principal investigator
INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO
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 positive pressure mechanical ventilatory support in people with Acute Respiratory Failure, run by Hospital Provincial de Castellon at 1 site in Spain.
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 10 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 22 Jun 2009. 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 Spain. 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 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?
mortality rates (time frame: patient hospital discharge). 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 22 Jun 2009.