Acute Respiratory FailureNCT00876473
Evaluation of Different Continuous Positive Airway Pressure (CPAP) Systems in Patients With Acute Respiratory Failure
An observational study of Acute Respiratory Failure, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- CPAP system
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Jan 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critically ill patients affected by Acute Respiratory Failure
Who may be able to join
- Intubated-tracheostomized subjects receiving CPAP during the weaning from invasive mechanical ventilation
Who cannot join
- Hemodynamic instability
- Barotrauma
- Severe myopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CPAP in Patients Affected by Acute Respiratory Failure
The aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.
Read the detailed description
Three CPAP systems are studied for each patient at the same level of PEEP: 1) continuous high-flow CPAP with fixed value PEEP valve; 2) continuous high-flow CPAP with Boussignac PEEP valve; 3) demand flow CPAP, supplied by a ventilator.
- Conditions
- Acute Respiratory Failure
- Being tested
- CPAP system
- Keywords
- CPAP, Acute Respiratory Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP systemProcedure or surgery
Evaluating the effects of different CPAP systems on respiratory mechanics, respiratory effort and gas-exchange
CPAP systems:
Continuous high-flow CPAP with fixed value PEEP valve
Continuous high-flow CPAP with Boussignac valve
Demand flow CPAP supplied by ventilator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Acute Respiratory Failure patients Receives: Procedure: CPAP system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange
Measured: 30 minutes
Secondary outcomes (1)
Comfort of breathing
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2014
- Study completionJan 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, Policlinico Hospital
- Investigators
- Davide Chiumello, MD, Principal investigator, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876473
- Sponsor's protocol ID
- 590
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2009
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CPAP in Patients Affected by Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT00876473
- Acronym / sponsor ID
- 590
- Conditions
- Acute Respiratory Failure
- Keywords
- CPAP, Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Apr 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 aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.
Detailed description
Three CPAP systems are studied for each patient at the same level of PEEP: 1) continuous high-flow CPAP with fixed value PEEP valve; 2) continuous high-flow CPAP with Boussignac PEEP valve; 3) demand flow CPAP, supplied by a ventilator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: CPAP systemAcute Respiratory Failure patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients affected by Acute Respiratory Failure
Key inclusion criteria (1 listed)
- Intubated-tracheostomized subjects receiving CPAP during the weaning from invasive mechanical ventilation
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Barotrauma
- Severe myopathy
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 |
|---|---|---|
| CPAP systemEvaluating the effects of different CPAP systems on respiratory mechanics, respiratory effort and gas-exchange CPAP systems: Continuous high-flow CPAP with fixed value PEEP valve Continuous high-flow CPAP with Boussignac valve Demand flow CPAP supplied by ventilator | Procedure or surgery | 1 |
Primary outcome
Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange
Time frame: 30 minutes
1 secondary outcome
Comfort of breathing
Time frame: 30 minutes
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 28 Apr 2015.
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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.
Davide Chiumello, MD principal investigator
Policlinico Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Policlinico Hospital 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 1 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 28 Apr 2015. 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.
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?
Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange (time frame: 30 minutes). 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 28 Apr 2015.