The use of non-invasive ventilation immediately after extubation to improve the weaning outcome in acute respiratory failure

ISRCTN	ISRCTN41524441
DOI	https://doi.org/10.1186/ISRCTN41524441
Protocol serial number	N/A
Sponsor	University of São Paulo Medical School (Brazil)
Funders	Hospital de Base University of São José de Rio Preto (Brazil), University of São Paulo Medical School (Brazil)

Submission date: 11/08/2008
Registration date: 21/08/2008
Last edited: 19/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Carmen Barbas
Scientific

Rua Maranhão 654 apto 174
São Paulo
01240-000
Brazil

Phone	+55 11 3826 1422
Email	cbarbas@attglobal.net

Study information

Primary study design	Interventional
Study design	Randomised, controlled, unblinded clinical study
Secondary study design	Randomised controlled trial
Scientific title	Efficacy of non-invasive positive pressure ventilation to prevent re-intubation and to improve hospital mortality after weaning in acute respiratory failure: a randomised, prospective study
Study objectives	Early application of non-invasive positive pressure ventilation immediately following elective extubation in more than three days of acute respiratory failure would decrease the need for re-intubation and hospital mortality compared to unassisted oxygen alone.
Ethics approval(s)	Ethics approval received from the Ethical Committee of São Paulo Medical School on the 13th December 2000 (ref: 885/00)
Health condition(s) or problem(s) studied	Acute respiratory failure
Intervention	After the patients achieved elective extubation criteria they were randomised to receive non-invasive positive pressure ventilation immediately after extubation or receive oxygen mask alone. The total duration for the treatment was 24 hours (use of noninvasive positive pressure ventilation after weaning). Reintubation criteria was reintubation required within a period of 48 hours after extubation. The need of reintubation was recorded as well as the length of ICU stay and hospital mortality. Joint sponsor details: Hospital de Base University of São José de Rio Preto (Brazil) Av. Brigadeiro Faria Lima 5544 Vila São Pedro CEP: 15090-000 São José do Rio Preto São Paulo Brazil Tel: +55 17 3201 5000 Fax: +55 17 3201 5000 Email: cbarbas@attglobal.net
Intervention type	Other
Primary outcome measure(s)	Decrement in the need of re-intubation, measured within 48 hours of extubation
Key secondary outcome measure(s)	1. Decrement of ICU length of stay 2. Decrement of hospital mortality
Completion date	15/01/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Patients aged 18 years or older, either sex 2. Need more than three days of mechanical ventilation administered by orotracheal intubation because of acute respiratory failure 3. Weaning from invasive mechanical ventilation using intensive care unit (ICU) weaning protocol 4. Absence of contraindications for the use of non-invasive ventilation
Key exclusion criteria	1. Less than 18 years of age 2. Pregnancy 3. Patients refusal to participate in the study
Date of first enrolment	15/01/1998
Date of final enrolment	15/01/1999

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Maranhão 654 apto 174

São Paulo
01240-000
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/03/2013		Yes	No