Proportional Assist Ventilation with adjustable gain factors versus Pressure Support ventilation in critically ill patients

ISRCTN	ISRCTN00104615
DOI	https://doi.org/10.1186/ISRCTN00104615
Protocol serial number	N/A
Sponsor	Cretan Critical Care Society (Greece)
Funder	Cretan Critical Care Society (Greece)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Dimitris Georgopoulos
Scientific

Intensive Care Unit
Heraklion University Hospital
Voutes
Heraklion
71110
Greece

Email	georgop@med.uoc.gr

Primary study design	Interventional
Study design	Randomised trial
Secondary study design	Randomised controlled trial
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(s)	1. PAV success rate 2. Sedation doses
Key secondary outcome measure(s)	1. Weaning time 2. Intensive Care Unit (ICU) mortality 3. Hospital mortality
Completion date	01/03/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Intensive Care Unit

Heraklion
71110
Greece

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	8 results	01/11/2008		Yes	No