Automatic versus manual pressure support reduction in the weaning of post-operative patients: a randomised, controlled trial

ISRCTN ISRCTN37456640
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

Av. Albert Einstein 627- 5 andar
São Paulo
05651-901
Brazil

Study information

Study designProspective, randomised, controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWeaning 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) studiedWeaning from mechanical ventilation
InterventionTo 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 typeProcedure/Surgery
Primary outcome measureDuration of weaning process.

Timepoints:
1. Start of ventilator triggering by the patient
2. Patient extubation
Secondary outcome measures1. 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 date01/08/2002
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Key inclusion criteriaAdult (more than 18 years old, either sex) mechanically ventilated post-operative ICU patients.
Key exclusion criteria1. Haemodynamic instability
2. Neurological surgeries
3. Previous pulmonary disease
Date of first enrolment01/08/2002
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • Brazil

Study participating centre

Av. Albert Einstein 627- 5 andar
São Paulo
05651-901
Brazil

Sponsor information

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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2009 Yes No
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