Comparison of non-invasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial vs conventional weaning

ISRCTN	ISRCTN32810409
DOI	https://doi.org/10.1186/ISRCTN32810409
Secondary identifying numbers	N0046182290

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Fang Gao
Scientific

Department of Anaesthetics
Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust
Bordelsey Green East
Birmingham
B9 5SS
United Kingdom

Phone	+44
Email	fang.smith@heartofengland.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparison of non-invasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial vs conventional weaning
Study acronym	NEXT
Study objectives	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(s)	Added September 2008: East Birmingham Local Research Ethical Committee (UK) Reference number 06/Q2703/19, May 2006.
Health condition(s) or problem(s) studied	Respiratory: Positive pressure ventilation
Intervention	Noninvasive positive pressure ventilation vs conventional weaning
Intervention type	Other
Primary outcome measure	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 study start date	13/03/2006
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Added September 2008: 90
Key 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
Key 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
Date of first enrolment	13/03/2006
Date of final enrolment	31/12/2009

Department of Anaesthetics

Birmingham
B9 5SS
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Heart of England NHS Foundation Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

15/03/2016: No publications found, verifying study status with principal investigator.