Acute Respiratory FailureNCT00538746
Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients
A study testing BIPAP, PSV and PSV + CPAP in people with Acute Respiratory Failure, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguately from acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- BIPAP, PSV and PSV + CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Feb 2005to 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Age higher than 18 yrs
- PaO2/FiO2 greater or equal than 150 with PEEP equal or lower than 10, and minute ventilation lower than 15 l/min
- Temperature lower than 38,5°C
- Stable hemodynamics: HR 60-125 b/min, SBP 90-160 mmHg without or with dopamine lower than 10 gamma/Kg/min or dobutamine lower than 10 gamma/Kg/min, no acute arrythmias
- Hb higher than 8 g/dl
- GCS higher or equal than 9
- The attending physician has to agree that the patient is in stable conditions and ready to be weaned from the ventilator
Who cannot join
- presence of chronic neuromuscular diseases
- need of surgical intervention within the next 72 hours
- difficult tracheal intubation
- tracheostomized patients
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale di Circolo e Fondazione Macchi
Varese, Varese, 21100
Paolo Pelosi, Professor, 0039-0332-278801, ppelosi@hotmail.com
Paolo Pelosi, Professor
About this study
Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguately from acute respiratory failure.
If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia, cardiac-associated morbility, and death. On the other hand, weaning too soon often results in reintubation, which is associated with complications similar to those of prolonged ventilation.
The aim of this trial is to establish an evidence-based approach to weaning and to determine when a patient is ready to be weaned from mechanical ventilation, and what is the best weaning technique.
- Conditions
- Acute Respiratory Failure
- Being tested
- BIPAP, PSV, PSV + CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAPDevice
PSVDevice
PSV + CPAPDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BIPAP (Bilevel Positive Airway Pressure) targeted on: TV 6-8 ml/kg, total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92% (with spontaneous RR between 20-40%) Receives: Device: BIPAP |
| 2 | Experimental | PSV (pressure support ventilation) targeted on: TV 6-8 ml/kg,total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92, a minimum of 7 cmH2O of PS is tolerated. Receives: Device: PSV |
| 3 | Experimental | PSV+CPAP (continuous positive airway pressure) targeted on: PSV: TV 6-8 ml/kg,total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92, a minimum of 7 cmH2O of PS is tolerated, CPAP (5-10 cmH2O) at least 2 hours a day. If during the CPAP periods at least 1 of the criteria T tube test failure occurs, the patients will come back immediately to PSV. Receives: Device: PSV + CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Days of intubation 2. Days of mechanical ventilation
Measured: 28 days
Secondary outcomes (1)
1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startFeb 2005
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Investigators
- Paolo Pelosi, Professor, Principal investigator, Universita' degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538746
- Sponsor's protocol ID
- 1500
- Status last verified
- Oct 2007
- First submitted
- 2 Oct 2007
- Last updated
- 3 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00538746
- Acronym / sponsor ID
- 1500
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Feb 2005
- First posted
- 3 Oct 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.
Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguately from acute respiratory failure.
If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia, cardiac-associated morbility, and death. On the other hand, weaning too soon often results in reintubation, which is associated with complications similar to those of prolonged ventilation.
The aim of this trial is to establish an evidence-based approach to weaning and to determine when a patient is ready to be weaned from mechanical ventilation, and what is the best weaning technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: BIPAPBIPAP (Bilevel Positive Airway Pressure) targeted on: TV 6-8 ml/kg, total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92% (with spontaneous RR between 20-40%) |
| 2 | Experimental | Device: PSVPSV (pressure support ventilation) targeted on: TV 6-8 ml/kg,total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92, a minimum of 7 cmH2O of PS is tolerated. |
| 3 | Experimental | Device: PSV + CPAPPSV+CPAP (continuous positive airway pressure) targeted on: PSV: TV 6-8 ml/kg,total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92, a minimum of 7 cmH2O of PS is tolerated, CPAP (5-10 cmH2O) at least 2 hours a day. If during the CPAP periods at least 1 of the criteria T tube test failure occurs, the patients will come back immediately to PSV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age higher than 18 yrs
- PaO2/FiO2 greater or equal than 150 with PEEP equal or lower than 10, and minute ventilation lower than 15 l/min
- Temperature lower than 38,5°C
- Stable hemodynamics: HR 60-125 b/min, SBP 90-160 mmHg without or with dopamine lower than 10 gamma/Kg/min or dobutamine lower than 10 gamma/Kg/min, no acute arrythmias
- Hb higher than 8 g/dl
Key exclusion criteria (4 listed)
- presence of chronic neuromuscular diseases
- need of surgical intervention within the next 72 hours
- difficult tracheal intubation
- tracheostomized patients
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 |
|---|---|---|
| BIPAP | Device | 1 |
| PSV | Device | 2 |
| PSV + CPAP | Device | 3 |
Primary outcome
1. Days of intubation 2. Days of mechanical ventilation
Time frame: 28 days
1 secondary outcome
1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 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.
Paolo Pelosi, Professor principal investigator
Universita' degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIPAP, PSV and PSV + CPAP in people with Acute Respiratory Failure, run by Università degli Studi dell'Insubria 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pelosi, Professor (0039-0332-278801, ppelosi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Days of intubation 2. Days of mechanical ventilation (time frame: 28 days). 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 3 Oct 2007.