NCT01204281

Brief Summary

To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+) (objective 80% gain) as main ventilatory support in early stage of critically ill patients in comparison with standard volume-assist control ventilation (ACV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

September 15, 2010

Last Update Submit

November 23, 2012

Conditions

Respiratory FailureMechanical Ventilation

Keywords

Proportional Assist Ventilation plusAcute respiratory failureMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Length of mechanical ventilation

    Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.

    28 days

Secondary Outcomes (3)

  • Non-inferiority of PAV+ compared to ACV in terms of gas exchange

    28 days

  • Noninferiority of PAV in short term complications

    28 days

  • Noninferiority of PAV in weaning success

    28 days

Study Arms (2)

High assistance PAV+

EXPERIMENTAL

Ventilatory support performed by PAV at 80% assistance (PB 840-plus) FiO2 and PEEP according to routine practice

Other: Mechanical ventilation mode (PAV+ vs. ACV)

Assist-control ventilation

ACTIVE COMPARATOR

Tidal volume, FiO2 and PEEP set according to routine practice

Other: Mechanical ventilation mode (PAV+ vs. ACV)

Interventions

Mechanical ventilation mode (PAV+ vs. ACV)OTHER

Compare two ventilatory modes in the acute phase of illness

Also known as: Proportional Assist ventilation (PAV+), Assist Control ventilation, Critically ill patients, Mechanical ventilation
Assist-control ventilationHigh assistance PAV+

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older
  • Anticipated MV \> 24 hours
  • Availability of informed consent from patient or next of kin
  • Ventilation parameters measured under PAV+ 80% gain:
  • PaO2/FiO2 \>100 RPAV \<10 cm H2O/l/s CPAV \> 30 ml/cm H2O WOBTOT \<1.5 J/l VE \<18 l/min

You may not qualify if:

  • Patients on moribund state or with life-sustaining therapy withholding decision.
  • Patients with unstable respiratory/hemodynamic state, PaO2/FiO2 \<100, Dopamine \>15 microg/Kg/min or epinephrine \>0.1 microg/kg/min.
  • Pregnancy.
  • Air leak.
  • Patients needing deep sedation or muscle paralysis
  • Patients needing hyperventilation (brain trauma).
  • Patients with severe muscle weakness.
  • Recruitment maneuvers or prone position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit. Xarxa assistencial Althaia.

Manresa, Catalonia, 08243, Spain

Location

Related Publications (5)

  • Grasso S, Puntillo F, Mascia L, Ancona G, Fiore T, Bruno F, Slutsky AS, Ranieri VM. Compensation for increase in respiratory workload during mechanical ventilation. Pressure-support versus proportional-assist ventilation. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):819-26. doi: 10.1164/ajrccm.161.3.9902065.

    PMID: 10712328RESULT

  • Georgopoulos, D., Plataki, M., Prinianakis, G., Kondili, E., Current status of proportional assist ventilation. International journal of Intensive Care, 2007. Autumn: p. 19-26.

    RESULT

  • Delgado M, Zavala E, Tomas R, Fernandez R. "Feasibility of proportional assist ventilation as routine ventilatory support in intensive care patients". Intensive Care Med 2009; 35; Suppl 1: S125

    RESULT

  • Putensen C, Muders T, Varelmann D, Wrigge H. The impact of spontaneous breathing during mechanical ventilation. Curr Opin Crit Care. 2006 Feb;12(1):13-8. doi: 10.1097/01.ccx.0000198994.37319.60.

    PMID: 16394778RESULT

  • Younes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64.

    RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Interactive Ventilatory SupportRespiration, Artificial

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsRespiratory TherapyResuscitationEmergency Treatment

Study Officials

  • Rafael Fernandez, M.D.

    Althaia Xarxa Assistencial Universitària de Manresa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Intensive Care Department

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 17, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

ES(1)