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ISRCTN
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ISRCTN32810409
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ClinicalTrials.gov identifier
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Public title
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Comparison of noninvasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial vs conventional weaning
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Scientific title
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Acronym
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NEXT
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Serial number at source
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N0046182290
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Study hypothesis
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The aim of this prospective randomised controlled study is to determine if patients who are attached to a breathing machine (ventilator) by a tube in the mouth who are unable to breathe unaided (invasive ventilation) can be safely removed from the ventilator and maintained with ventilation via a face mask (noninvasive ventilation) for approximately 24 hours before withdrawal of NIV support.
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Ethics approval
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Added September 2008: East Birmingham Local Research Ethical Committee (UK) Reference number 06/Q2703/19, May 2006.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory: Positive pressure ventilation
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Participants - inclusion criteria
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1. Patients will need to meet the criteria for reducing breathing support - will not be weaned until physiologically ready.
2. Patients will have to be on a breathing machine attached to a tube in the mouth for at least 48 hours - patients who are on a breathing machine for <48 hours are not seen as difficult to wean from a ventilator
3. Age > 18 years - patient should be able to make own legal judgements to treatment
4. Written informed consent obtained - unethical to carry out study without consent
5. Failed an attempt to try breathing without help - study only being carried out on people who have difficulty with weaning
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Participants - exclusion criteria
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Added September 2008:
1. Patients who are generally not suitable for noninvasive ventilationGrade III/IV intubation
2. Gastric/oesophageal surgery on this admission
3. Patients who it has been decided would not be for re-intubation once extubated
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Anticipated start date
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13/03/2006
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Anticipated end date
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31/12/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Added September 2008: 90
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Interventions
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Noninvasive positive pressure ventilation vs conventional weaning
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Primary outcome measure(s)
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Duration of time with breathing support tube in the mouth in days
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Secondary outcome measure(s)
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Length of intensive care unit and hospital stay in days
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Sources of funding
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Heart of England NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Fang
Gao
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Address
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Department of Anaesthetics
Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust
Bordelsey Green East
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City/town
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Birmingham
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Zip/Postcode
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B9 5SS
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Country
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United Kingdom
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Tel
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+44
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Fax
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+44
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Email
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fang.smith@heartofengland.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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15/09/2008
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Date ISRCTN assigned
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28/09/2007
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