Sedation During Noninvasive Ventilation (NIV) (REMI)
Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure.
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)
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Bologna, Italien, 40138
- Rekruttering
- san'Orsola Malpighi Hospital, Bologna ITALY
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Ph<7,35 and PaCO2>50 mmHg with acute respiratory failure
- 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:
- Patients responding well to NIV and not showing signs of poor synchrony
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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patient-ventilator interaction
Tidsramme: one hour
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patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
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one hour
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matching of inspiratory timing
Tidsramme: one hour
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the patients inspiratory time vs ventilator inspiratory time
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one hour
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Wasted efforts
Tidsramme: one hour
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breaths unable to trigger the ventilator
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one hour
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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NIV failure
Tidsramme: one hour
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failure will be defined as the need for intubation:
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one hour
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Stefano Nava, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 116/2014O
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