Proportional Assist Ventilation with adjustable gain factors versus Pressure Support ventilation in critically ill patients
| ISRCTN | ISRCTN00104615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00104615 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/09/2006
- Registration date
- 13/10/2006
- Last edited
- 30/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dimitris Georgopoulos
Scientific
Scientific
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
| georgop@med.uoc.gr |
Study information
| Study design | Randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PAV vs PS |
| Study objectives | To access the success rate and efficacy of Proportional Assist Ventilation (PAV) with adjustable gain factors versus Pressure Support (PS) in critically ill patients receiving controlled mechanical ventilation. |
| Ethics approval(s) | Ethics committee of Heraklion University Hospital (reference number: 6122), date of approval: 30/05/2006. |
| Health condition(s) or problem(s) studied | Respiratory disorders requiring mechanical ventilation |
| Intervention | After enrolment PAV with adjustable gain factors or pressure support will be instigated and the patients will be monitored during the following 48 hours. Patients who meet any of the predefined failure criteria during this period are returned to controlled mechanical ventilation. |
| Intervention type | Other |
| Primary outcome measure | 1. PAV success rate 2. Sedation doses |
| Secondary outcome measures | 1. Weaning time 2. Intensive Care Unit (ICU) mortality 3. Hospital mortality |
| Overall study start date | 30/05/2006 |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 250 |
| Key inclusion criteria | 1. Critically ill patients receiving control mechanical ventilation for at least 36 hours 2. Partial Pressure of Oxygen in Arterial Blood (PaO2) more than 65 mmHg, Fraction of Inspired Oxygen (FiO2) less than 65% and Positive End Expiratory Pressure (PEEP) level less than 15 mmHg 3. No respiratory distress |
| Key exclusion criteria | 1. Aged over 18 and under 85 years 2. Severe haemodynamic instability 3. Pregnancy 4. Neuromuscular disorders 5. End stage disease 6. Severe bronchospasm, resistance of the respiratory system more than 20 |
| Date of first enrolment | 30/05/2006 |
| Date of final enrolment | 01/03/2008 |
Locations
Countries of recruitment
- Greece
Study participating centre
Intensive Care Unit
Heraklion
71110
Greece
71110
Greece
Sponsor information
Cretan Critical Care Society (Greece)
Hospital/treatment centre
Hospital/treatment centre
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
| georgop@med.uoc.gr |
Funders
Funder type
Research organisation
Cretan Critical Care Society (Greece)
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 | 8 results | 01/11/2008 | Yes | No |
