To assess the predictive value of the respiratory mode, automatic tube compensation, in the process of weaning from mechanical ventilation compared to another mode, namely pressure support ventilation
| ISRCTN | ISRCTN16080446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16080446 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/09/2008
- Registration date
- 29/09/2008
- 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
Dr Jonathan Cohen
Scientific
Scientific
General Intensive Care
Petah Tikva
49100
Israel
Study information
| Study design | Single-centre, interventional, randomised, controlled, prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prediction of extubation outcome: a randomised, controlled trial with automatic tube compensation versus pressure support ventilation |
| Study objectives | 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(s) | Helsinki Board of Rabin Medical Centre granted approval in April 2006 (ref: 2038). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2006 |
| Completion date | 04/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 |
| Key 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 |
| Key exclusion criteria | Does not comply with the above inclusion criteria. |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 04/04/2008 |
Locations
Countries of recruitment
- Israel
Study participating centre
General Intensive Care
Petah Tikva
49100
Israel
49100
Israel
Sponsor information
Rabin Medical Center (Israel)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Jonathan Cohen
General Intensive Care
Petah Tikva
49100
Israel
| Website | http://www.clalit.org.il/he-il |
|---|---|
"ROR" |
https://ror.org/01vjtf564 |
Funders
Funder type
Hospital/treatment centre
Rabin Medical Center (Israel)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2009 | Yes | No |
