Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2014-10-31
2017-10-31
Brief Summary
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This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
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Detailed Description
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This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing.
The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
In this physiological study the investigators will study 15 patients at risk of failing NIV because of scarce tolerance and showing clinical signs of poor interaction with the ventilator.
Once the patient will be enrolled the investigators will record using the balloon-catheter technique the online measurement of respiratory mechanics, to assess the inspiratory muscle effort and the matching between the patient breathing pattern and that of the ventilator The investigators will also record the clinical success of sedation (i.e. need or not for endotracheal intubation)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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acutely ill patients
administration of remifentanil at the infusion rate by 0.025 μg kg-1 min-1 to a maximum of 0.10 μg kg-1 min-1.
Remifentanil
infusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1.
Interventions
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Remifentanil
infusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signs of respiratory distress and poor synchrony with the ventilator as assessed on the ventilator screen and by looking patient own rate and ventilator recorded rate
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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dr. Stefano Nava
Professor of Respiratory Medicine
Principal Investigators
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stefano nava, md
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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San'Orsola Malpighi Hospital, Bologna ITALY
Bologna, , Italy
Countries
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Central Contacts
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stefano nava, md
Role: CONTACT
Facility Contacts
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Other Identifiers
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116/2014O
Identifier Type: -
Identifier Source: org_study_id
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