Contact information
Type
Scientific
Primary contact
Prof Carmen Barbas
ORCID ID
Contact details
Rua Maranhão 654 apto 174
São Paulo
01240-000
Brazil
+55 11 3826 1422
cbarbas@attglobal.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Ethics approval received from the Ethical Committee of São Paulo Medical School on the 13th December 2000 (ref: 885/00)
Study design
Randomised, controlled, unblinded clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Decrement in the need of re-intubation, measured within 48 hours of extubation
Secondary outcome measures
1. Decrement of ICU length of stay
2. Decrement of hospital mortality
Overall trial start date
15/01/1998
Overall trial end date
15/01/1999
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients
Participant exclusion criteria
1. Less than 18 years of age
2. Pregnancy
3. Patients refusal to participate in the study
Recruitment start date
15/01/1998
Recruitment end date
15/01/1999
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Maranhão 654 apto 174
São Paulo
01240-000
Brazil
Sponsor information
Organisation
University of São Paulo Medical School (Brazil)
Sponsor details
Av. Dr Eneas de Carvalho Aguiar 255
Sala 7079
São Paulo
05403-900
Brazil
+55 11 3826 1422
cbarbas@attglobal.net
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital de Base University of São José de Rio Preto (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of São Paulo Medical School (Brazil)
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
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23497557
Publication citations
-
Results
Ornico SR, Lobo SM, Sanches HS, Deberaldini M, Tófoli LT, Vidal AM, Schettino GP, Amato MB, Carvalho CR, Barbas CS, Noninvasive ventilation immediately after extubation improves weaning outcome after acute respiratory failure: a randomized controlled trial., Crit Care, 2013, 17, 2, R39, doi: 10.1186/cc12549.