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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Rua Maranhão 654 apto 174
São Paulo
01240-000
Brazil
| Phone | +55 11 3826 1422 |
|---|---|
| cbarbas@attglobal.net |
Study information
| Study design | Randomised, controlled, unblinded clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 15/01/1998 |
| Completion date | 15/01/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 patients |
| 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
01240-000
Brazil
Sponsor information
University of São Paulo Medical School (Brazil)
University/education
University/education
Av. Dr Eneas de Carvalho Aguiar 255
Sala 7079
São Paulo
05403-900
Brazil
| Phone | +55 11 3826 1422 |
|---|---|
| cbarbas@attglobal.net | |
"ROR" |
https://ror.org/036rp1748 |
Funders
Funder type
Hospital/treatment centre
Hospital de Base University of São José de Rio Preto (Brazil)
No information available
University of São Paulo Medical School (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
