Weaning From Mechanical VentilationNCT03018483
Mechanical Ventilation- Weaning and Thoracic Impedance Tomography
A study testing Variable PSV, Conventional PSV and Automated PSV in people with Weaning From Mechanical Ventilation, run by Federico II University at 1 site in Italy.
Trial summary
The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM. This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation
- What is being tested?
- Variable PSV, Conventional PSV and Automated PSV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2017to 1 Dec 2019
- 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
- age≥18 years
- duration of controlled mechanical ventilation≥ 24 h
- temperature≤ 39°C
- hemoglobin≥ 6 g/dl
- ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction - PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O
- ability of the patient to breathe spontaneously
- informed consent
Who cannot join
- patient participated in another interventional trial within the last four weeks before enrollment
- peripheral neurological disease associated with impairment of the respiratory pump
- muscular disease associated with impairment of the respiratory pump
- unstable thorax with paradoxical chest wall movement
- planned surgery under general anesthesia within 72 hours
- difficult airway or intubation
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- existing tracheotomy at ICU admission
- expected survival<72 hours
- home mechanical ventilation or on chronic oxygen therapy
- suspected or confirmed pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Naples
Naples, 80100
maria vargas, MD, vargas.maria82@gmail.com
About this study
Official title: Comparison Between Automated Pressure Support Ventilation, Variable Pressure Support Ventilation and Non-variable Pressure Support Ventilation in Weaning From Mechanical Ventilation
The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.
This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation for more than 24 hours who are able to be weaned.
The aim of the study is to determine the duration of weaning from mechanical ventilation for each one of the above mentioned weaning methods
- Conditions
- Weaning From Mechanical Ventilation
- Being tested
- Variable PSV, Conventional PSV, Automated PSV, NAVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable PSVDevice
Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.
In patients ventilated with variable PSV, the pressure support variability is as high as possible (up to 100%), while not exceeding the maximal inspiratory pressure determined by the treating physician.
Conventional PSVDevice
Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. The adjustment of pressure support until extubation follows these rules for both non-variable and variable PSV groups: pressure support is gradually adjusted in decrements (or increments) of 0 to 5 cmH2O. PEEP is decreased in steps of 0 to 5 cmH2O; PEEP and FiO2 are adjusted to achieve a SaO2 ≥92%, with a PEEP ≥5 cmH2O.
Automated PSVDevice
Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.Smart CareTM as total automated procedure will be used.
NAVADevice
NAVA level is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the Edi level was increased by step of 0,2 cm/h2o/ mcvolt, PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Variable PSV | Experimental | Not described Receives: Device: Variable PSV |
| Conventional PSV | Active comparator | Not described Receives: Device: Conventional PSV |
| Automated PSV | Active comparator | Not described Receives: Device: Automated PSV |
| NAVA | Active comparator | Not described Receives: Device: NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning time
weaning time defined as the time from randomization to successful extubation.
Measured: within 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start1 May 2017
- Primary completion1 May 2019
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning From Mechanical VentilationStudies 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)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Vargas, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018483
- Sponsor's protocol ID
- PSWEAN and EIT
- Status last verified
- Dec 2019
- First submitted
- 4 Jan 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Automated Pressure Support Ventilation, Variable Pressure Support Ventilation and Non-variable Pressure Support Ventilation in Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03018483
- Acronym / sponsor ID
- PSWEAN and EIT
- Conditions
- Weaning From Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 12 Jan 2017 (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 multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.
This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation for more than 24 hours who are able to be weaned.
The aim of the study is to determine the duration of weaning from mechanical ventilation for each one of the above mentioned weaning methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Variable PSV | Experimental | Device: Variable PSV |
| Conventional PSV | Active comparator | Device: Conventional PSV |
| Automated PSV | Active comparator | Device: Automated PSV |
| NAVA | Active comparator | Device: NAVA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age≥18 years
- duration of controlled mechanical ventilation≥ 24 h
- temperature≤ 39°C
- hemoglobin≥ 6 g/dl
- ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction - PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O
Key exclusion criteria (10 listed)
- patient participated in another interventional trial within the last four weeks before enrollment
- peripheral neurological disease associated with impairment of the respiratory pump
- muscular disease associated with impairment of the respiratory pump
- unstable thorax with paradoxical chest wall movement
- planned surgery under general anesthesia within 72 hours
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 |
|---|---|---|
| Variable PSVPressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. In patients ventilated with variable PSV, the pressure support variability is as high as possible (up to 100%), while not exceeding the maximal inspiratory pressure determined by the treating physician. | Device | Variable PSV |
| Conventional PSVPressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. The adjustment of pressure support until extubation follows these rules for both non-variable and variable PSV groups: pressure support is gradually adjusted in decrements (or increments) of 0 to 5 cmH2O. PEEP is decreased in steps of 0 to 5 cmH2O; PEEP and FiO2 are adjusted to achieve a SaO2 ≥92%, with a PEEP ≥5 cmH2O. | Device | Conventional PSV |
| Automated PSVPressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.Smart CareTM as total automated procedure will be used. | Device | Automated PSV |
| NAVANAVA level is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the Edi level was increased by step of 0,2 cm/h2o/ mcvolt, PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. | Device | NAVA |
Primary outcome
weaning time
Time frame: within 6 hours
weaning time defined as the time from randomization to successful extubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable PSV, Conventional PSV and Automated PSV in people with Weaning From Mechanical Ventilation, run by Federico II University 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 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: status not confirmed, as of the sponsor's last update on 11 Dec 2019. 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 Maria Vargas (+39 3396876440, vargas.maria82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning time (time frame: within 6 hours). 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 11 Dec 2019.