Condition category
Respiratory
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
15/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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