Condition category
Surgery
Date applied
22/06/2008
Date assigned
16/07/2008
Last edited
12/03/2010
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

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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)

Study design

Prospective, randomised, controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2002

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Adult (more than 18 years old, either sex) mechanically ventilated post-operative ICU patients.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Haemodynamic instability
2. Neurological surgeries
3. Previous pulmonary disease

Recruitment start date

01/08/2002

Recruitment end date

01/01/2004

Locations

Countries of recruitment

Brazil

Trial participating centre

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

Sponsor information

Organisation

Albert Einstein Hospital (Brazil)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.einstein.br

Funders

Funder type

Hospital/treatment centre

Funder name

Albert Einstein Hospital (Brazil) - Human Resources

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Air Liquide Brasil Ltda (Brazil) - Taema HORUS Ventilator, lent for 2 years

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19171056

Publication citations

  1. Results

    Taniguchi C, Eid RC, Saghabi C, Souza R, Silva E, Knobel E, Paes AT, Barbas CS, Automatic versus manual pressure support reduction in the weaning of post-operative patients: a randomised controlled trial., Crit Care, 2009, 13, 1, R6, doi: 10.1186/cc7695.

Additional files

Editorial Notes