| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN32810409 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0046182290 |
| Public title | Comparison of noninvasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial vs conventional weaning |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Respiratory: Positive pressure ventilation |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients will need to meet the criteria for reducing breathing support - will not be weaned until psychologically 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 13/03/2006 |
| Anticipated end date | 13/03/2007 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Noninvasive positive pressure ventilation vs conventional weaning |
| Primary outcome measure(s) | 1. Duration of time with breathing support tube in the mouth in days
2. Length of intensive care unit and hospital stay in days |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Heart of England NHS Foundation Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Fang Gao |
| Contact details | Department of Anaesthetics
Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust
Bordelsey Green East
Birmingham
United Kingdom
B9 5SS |
| Contact telephone | +44 43438 |
| Contact fax | +44 |
| Contact email | fang.smith@heartofengland.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN32810409 |
| Date last extracted from ISRCTN register | 17/04/2008 |
