Contact information
Type
Scientific
Primary contact
Prof Dimitris Georgopoulos
ORCID ID
Contact details
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
georgop@med.uoc.gr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PAV vs PS
Study hypothesis
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
Ethics committee of Heraklion University Hospital (reference number: 6122), date of approval: 30/05/2006.
Study design
Randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
30/05/2006
Overall trial end date
01/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant 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
Recruitment start date
30/05/2006
Recruitment end date
01/03/2008
Locations
Countries of recruitment
Greece
Trial participating centre
Intensive Care Unit
Heraklion
71110
Greece
Sponsor information
Organisation
Cretan Critical Care Society (Greece)
Sponsor details
Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece
georgop@med.uoc.gr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Cretan Critical Care Society (Greece)
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
Basic results (scientific)
Publication list
208 results in http://www.ncbi.nlm.nih.gov/pubmed/18607562
Publication citations
-
Xirouchaki N, Kondili E, Vaporidi K, Xirouchakis G, Klimathianaki M, Gavriilidis G, Alexandopoulou E, Plataki M, Alexopoulou C, Georgopoulos D, Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support., Intensive Care Med, 2008, 34, 11, 2026-2034, doi: 10.1007/s00134-008-1209-2.