Contact information
Type
Scientific
Primary contact
Dr Fang Gao
ORCID ID
Contact details
Department of Anaesthetics
Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust
Bordelsey Green East
Birmingham
B9 5SS
United Kingdom
+44
fang.smith@heartofengland.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0046182290
Study information
Scientific title
Comparison of non-invasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial vs conventional weaning
Acronym
NEXT
Study hypothesis
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.
Ethics approval
Added September 2008: East Birmingham Local Research Ethical Committee (UK) Reference number 06/Q2703/19, May 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory: Positive pressure ventilation
Intervention
Noninvasive positive pressure ventilation vs conventional weaning
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Duration of time with breathing support tube in the mouth in days
Secondary outcome measures
Length of intensive care unit and hospital stay in days
Overall trial start date
13/03/2006
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Added September 2008: 90
Participant exclusion criteria
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
Recruitment start date
13/03/2006
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Heart of England NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary