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Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure

14. april 2021 opdateret af: ResMed

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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
Enhed: AutoVPAP™
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.
Andre navne:
  • autotitrerende variabelt positivt luftvejstryk
  • autotitrerende NIV
  • automatisk titrering af NIV
Aktiv komparator: Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
Enhed: VPAPIIIST-A™
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.
Andre navne:
  • standard NIV
  • standard ikke-invasiv ventilator
  • variabelt positivt luftvejstryk
  • VPAP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pH at 1+ hour
Tidsramme: 1 hour
pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
1 hour

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pH at 4+ hours
Tidsramme: 4+ hours of NIV treatment
pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value
4+ hours of NIV treatment
Respiratory Rate at 1+ hour
Tidsramme: 1+ hour of NIV treatment
Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value
1+ hour of NIV treatment
Respiratory rate at 4+ hours
Tidsramme: 4+ hours of NIV treatment
Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value
4+ hours of NIV treatment
overnight mean transcutaneous carbon dioxide
Tidsramme: 24 hours
mean overnight transcutaneous carbon dioxide during sleep period
24 hours
PaCO2 at 1+ hours
Tidsramme: 1+ hours of NIV treatment
Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline
1+ hours of NIV treatment
PaCO2 at 4+ hours
Tidsramme: 4+ hours of NIV treatment
Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value
4+ hours of NIV treatment
PaO2 at 1+ hour
Tidsramme: 1+ hour of NIV treatment
Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value
1+ hour of NIV treatment
PaO2 at 4+ hours
Tidsramme: 4+ hours of NIV treatment
Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value
4+ hours of NIV treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ResMed

Samarbejdspartnere

Royal Brompton & Harefield NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2010

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Faktiske)

10. maj 2011

Datoer for studieregistrering

Først indsendt

2. august 2010

Først indsendt, der opfyldte QC-kriterier

2. august 2010

Først opslået (Skøn)

3. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10/H0808/56
  • R&D No. 2010LF008B (Anden identifikator: Research & Development Department, RBH)
  • CI/2010/0027 (Anden identifikator: Medicines & Healthcare Products Regularoty Agency (devices))

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