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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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London, Regno Unito, SW3 6NP
- Royal Brompton Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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pH at 1+ hour
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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pH at 4+ hours
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Malattie delle vie respiratorie
- Apnea
- Disturbi respiratori
- Disturbi del sonno, intrinseci
- Dissonnie
- Disturbi del sonno e della veglia
- Malattie polmonari
- Ipernutrizione
- Disturbi della nutrizione
- Segni e sintomi, respiratori
- Sindromi da apnee notturne
- Obesità
- Apnea notturna, ostruttiva
- Malattie polmonari, ostruttive
- Malattia polmonare, cronica ostruttiva
- Insufficienza respiratoria
- Ipoventilazione
- Obesità Sindrome da ipoventilazione
- Malattie neuromuscolari
Altri numeri di identificazione dello studio
- 10/H0808/56
- R&D No. 2010LF008B (Altro identificatore: Research & Development Department, RBH)
- CI/2010/0027 (Altro identificatore: Medicines & Healthcare Products Regularoty Agency (devices))
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