Condition category
Respiratory
Date applied
11/08/2008
Date assigned
21/08/2008
Last edited
19/03/2013
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

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

  1. 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.

Additional files

Editorial Notes