Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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London, Vereinigtes Königreich, SW3 6NP
- Royal Brompton Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
Exclusion Criteria:
- < 18 years old
- pH < 7.25
- need for immediate intubation
- uncontrolled cardiac failure
- hypotensive (systolic blood pressure < 90mmHg)
- acute myocardial infarction
- acute dysrhythmia
- other system failure (e.g. acute renal failure, liver failure)
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
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Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Andere Namen:
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Aktiver Komparator: Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
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Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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pH at 1+ hour
Zeitfenster: 1 hour
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pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
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1 hour
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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pH at 4+ hours
Zeitfenster: 4+ hours of NIV treatment
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pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value
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4+ hours of NIV treatment
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Respiratory Rate at 1+ hour
Zeitfenster: 1+ hour of NIV treatment
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Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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Respiratory rate at 4+ hours
Zeitfenster: 4+ hours of NIV treatment
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Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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overnight mean transcutaneous carbon dioxide
Zeitfenster: 24 hours
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mean overnight transcutaneous carbon dioxide during sleep period
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24 hours
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PaCO2 at 1+ hours
Zeitfenster: 1+ hours of NIV treatment
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Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline
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1+ hours of NIV treatment
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PaCO2 at 4+ hours
Zeitfenster: 4+ hours of NIV treatment
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Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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PaO2 at 1+ hour
Zeitfenster: 1+ hour of NIV treatment
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Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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PaO2 at 4+ hours
Zeitfenster: 4+ hours of NIV treatment
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Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Erkrankungen der Atemwege
- Apnoe
- Atemstörungen
- Schlafstörungen, intrinsisch
- Dyssomnien
- Schlaf-Wach-Störungen
- Lungenkrankheit
- Überernährung
- Ernährungsstörungen
- Anzeichen und Symptome, Atmung
- Schlafapnoe-Syndrome
- Fettleibigkeit
- Schlafapnoe, obstruktiv
- Lungenerkrankungen, obstruktive
- Lungenerkrankung, chronisch obstruktiv
- Ateminsuffizienz
- Hypoventilation
- Adipositas-Hypoventilationssyndrom
- Neuromuskuläre Erkrankungen
Andere Studien-ID-Nummern
- 10/H0808/56
- R&D No. 2010LF008B (Andere Kennung: Research & Development Department, RBH)
- CI/2010/0027 (Andere Kennung: Medicines & Healthcare Products Regularoty Agency (devices))
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