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
Protocol serial number	N/A
Sponsor	Albert Einstein Hospital (Brazil)
Funders	Albert Einstein Hospital (Brazil) - Human Resources, Air Liquide Brasil Ltda (Brazil) - Taema HORUS Ventilator, lent for 2 years

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

Primary study design	Interventional
Study design	Prospective, randomised, controlled clinical trial
Secondary study design	Randomised controlled trial
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(s)	Duration of weaning process. Timepoints: 1. Start of ventilator triggering by the patient 2. Patient extubation
Key secondary outcome measure(s)	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
Completion date	01/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/01/2009		Yes	No