Condition category
Surgery
Date applied
15/09/2008
Date assigned
29/09/2008
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

Dr Jonathan Cohen

ORCID ID

Contact details

General Intensive Care
Petah Tikva
49100
Israel

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prediction of extubation outcome: a randomised, controlled trial with automatic tube compensation versus pressure support ventilation

Acronym

Study hypothesis

The use of automatic tube compensation during a spontaneous breathing trial would have an advantage over pressure support in predicting successful extubation outcome.

Ethics approval

Helsinki Board of Rabin Medical Centre granted approval in April 2006 (ref: 2038).

Study design

Single-centre, interventional, randomised, controlled, prospective study

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

Patients are blindly allocated to undergo a 1-hour spontaneous breathing trial with either automatic tube compensation (ATC) (patients breathed through the ventilatory circuit using flow-triggering and CPAP of 5 cm H2O, FiO2 less than 0.5 with the addition of ATC 100%, the ATC group) or pressure support ventilation (PSV) (patients breathed through the ventilatory circuit using flow-triggering and CPAP of 5 cm H2O, FiO2 less than 0.5 with the addition of 7 cm H2O of pressure support, the PSV group). Patients tolerating the breathing trial underwent immediate extubation while patients not tolerating the trial were reconnected to the ventilator. Patients were followed up for 48 hours following extubation.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Tolerance of the spontaneous breathing trial: ability to maintain spontaneous breathing for greater than 48 hours after extubation.

Secondary outcome measures

Predictive value of the frequency to tidal volume ratio with ATC compared to the ratio without ATC.

Overall trial start date

01/10/2006

Overall trial end date

04/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age range 18 - 76 years, either sex, in the intensive care unit
2. Have required mechanical ventilation for greater than 24 hours
3. Meet criteria for weaning:
3.1. Improvement of the cause of respiratory failure
3.2. Oxygen saturation greater than 92% with a fraction of inspired oxygen (FiO2) of less than 50%
3.3. Stable neurological status (Glasgow Coma Score [GCS] greater than 8)
3.4. Require bronchial toilet less than twice in the 8 hours preceding the assessment
3.5. No need for vasoactive drugs
3.6. Receiving only minimal or no sedation
3.7. Body temperature greater than 36°C and less than 38°C
3.8. Level of pressure support less than 15 cm H2O with a positive end-expiratory pressure (PEEP) level of 8 cm H2O or less

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

Does not comply with the above inclusion criteria.

Recruitment start date

01/10/2006

Recruitment end date

04/04/2008

Locations

Countries of recruitment

Israel

Trial participating centre

General Intensive Care
Petah Tikva
49100
Israel

Sponsor information

Organisation

Rabin Medical Center (Israel)

Sponsor details

c/o Dr Jonathan Cohen
General Intensive Care
Petah Tikva
49100
Israel

Sponsor type

Hospital/treatment centre

Website

http://www.clalit.org.il/he-il

Funders

Funder type

Hospital/treatment centre

Funder name

Rabin Medical Center (Israel)

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/19236688

Publication citations

  1. Results

    Cohen J, Shapiro M, Grozovski E, Fox B, Lev S, Singer P, Prediction of extubation outcome: a randomised, controlled trial with automatic tube compensation vs. pressure support ventilation., Crit Care, 2009, 13, 1, R21, doi: 10.1186/cc7724.

Additional files

Editorial Notes