Automatic versus manual pressure support reduction in the weaning of post-operative patients: a randomised, controlled trial
ISRCTN | ISRCTN37456640 |
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DOI | https://doi.org/10.1186/ISRCTN37456640 |
Secondary identifying numbers | N/A |
- Submission date
- 22/06/2008
- Registration date
- 16/07/2008
- Last edited
- 12/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Av. Albert Einstein 627- 5 andar
São Paulo
05651-901
Brazil
Study information
Study design | Prospective, randomised, controlled clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Weaning with mandatory rate ventilation is as fast and secure as the manual decrement of pressure support ventilation during a weaning trial in the post-operative intensive care unit (ICU) mechanically ventilated patients. |
Ethics approval(s) | Ethics approval received from: 1. The Ethical Committee of Albert Einstein Hospital on the 29th July 2002 (ref: 61/02) 2. The Ethical Committee of São Paulo Medical School (University of São Paulo-Brazil) in July 2006 (ref: 372/06) |
Health condition(s) or problem(s) studied | Weaning from mechanical ventilation |
Intervention | To compare two methods of weaning from mechanical ventilation: manual reduction of pressure support (every thirty minutes) versus automatic and computerised method (mandatory rate ventilation) in post-operative mechanically ventilated adult ICU patients. The total duration of the weaning trial was 205 +/- 181 minutes ( 30 to 840 minutes) for the manual group and 157+/- minutes (30 to 545 minutes) for the automatic group. The patients were followed up for 48 hours after extubation. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Duration of weaning process. Timepoints: 1. Start of ventilator triggering by the patient 2. Patient extubation |
Secondary outcome measures | 1. Levels of pressure support, from the start of spontaneous breathing till extubation 2. Respiratory rate, from the start of spontaneous breathing till extubation 3. Tidal volume, from the start of spontaneous breathing till extubation 4. Respiratory rate/tidal volume (L), from the start of spontaneous breathing till extubation 5. Fraction of inspired oxygen (FIO2), positive end expiratory pressure (PEEP) levels and oxygen saturation during the weaning process, from the start of spontaneous breathing till extubation 6. Need of re-intubation or need of non-invasive ventilation after 48 hours of extubation |
Overall study start date | 01/08/2002 |
Completion date | 01/01/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 80 |
Key inclusion criteria | Adult (more than 18 years old, either sex) mechanically ventilated post-operative ICU patients. |
Key exclusion criteria | 1. Haemodynamic instability 2. Neurological surgeries 3. Previous pulmonary disease |
Date of first enrolment | 01/08/2002 |
Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av. Albert Einstein 627- 5 andar
São Paulo
05651-901
Brazil
05651-901
Brazil
Sponsor information
Albert Einstein Hospital (Brazil)
Hospital/treatment centre
Hospital/treatment centre
Av. Albert Einsten 627 -5 andar
São Paulo
05651-901
Brazil
Website | http://www.einstein.br |
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https://ror.org/04cwrbc27 |
Funders
Funder type
Hospital/treatment centre
Albert Einstein Hospital (Brazil) - Human Resources
No information available
Air Liquide Brasil Ltda (Brazil) - Taema HORUS Ventilator, lent for 2 years
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/01/2009 | Yes | No |