Condition category
Respiratory
Date applied
15/09/2006
Date assigned
13/10/2006
Last edited
30/10/2008
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

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 measures

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

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

Results - basic reporting

Publication summary

208 results in http://www.ncbi.nlm.nih.gov/pubmed/18607562

Publication citations

  1. 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.

Additional files

Editorial Notes