Comparison of Weaning on Pressure Support vs. Proportional Assist Ventilation: A Pilot Study

NCT ID: NCT01666054

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-07-31

Brief Summary

The study hypothesis is that reducing patient-ventilator asynchrony will reduce time required to wean from mechanical ventilation. The purpose of this pilot study is (1) to assess study feasibility in terms of recruitment, protocol adherence and efficacy of the intervention for reducing asynchrony, (2) to assess baseline rates of asynchrony and outcomes in the control arm in order to perform sample size calculations, if needed, for further, larger studies designed to detect differences in weaning time in specific, predefined populations and (3) to examine how often ineffective triggering (and therefore reduced ventilator respiratory rate) at higher levels of pressure support lead to a false conclusion that higher levels of support are needed to diminish respiratory distress.

Detailed Description

Previous research has shown that approximately twenty-five percent of patients capable of triggering the ventilator in assisted modes have high rates of patient-ventilator asynchrony, and that such patients have a longer duration of mechanical ventilation. It is not known whether asynchrony is a cause of weaning failure or simply a marker of more severe respiratory failure. The most common type of asynchrony, ineffective triggering, may be both a marker of respiratory disease and a cause of delayed weaning. During ineffective triggering, the patient's inspiratory effort fails to trigger a ventilator breath, and thus the respiratory rate displayed on the ventilator underestimates the patient's true, intrinsic respiratory rate. Since ineffective triggering is more common at higher levels of pressure support than lower levels, an increase in respiratory rate during weaning of pressure support may indicate the development of respiratory distress or simply the abolition of ineffective triggering. Ineffective triggering may also cause delayed weaning because respiratory muscle energy is "wasted" on non-supported breaths. Proportional assist ventilation (PAV) is an FDA- and HPB-approved mode of ventilation in which the ventilator applies pressure in proportion to patient effort. Using PAV, patient-ventilator interaction may be optimized and ineffective triggering greatly reduced. Since the patient and ventilator respiratory rates are generally equivalent, a reduction in respiratory rate with increasing ventilatory support is less likely to be false positive indication of the need for greater assistance.

In this study, patients with difficulty weaning from mechanical ventilation will be randomized to weaning with one of two weaning protocols: Proportional Assist Ventilation (PAV) weaning algorithm (intervention arm) vs. Pressure Support Ventilation (PSV) weaning algorithm (control arm).

Conditions

Weaning From Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proportional Assist Ventilation (PAV)

Proportional Assist Ventilation (PAV+ on the PB840 ventilator) will be used according to a weaning algorithm. If patients develop distress despite maximum levels of support on PAV+, they will be temporarily switched to assist control mode.

Group Type: ACTIVE_COMPARATOR

PAV

Intervention Type: OTHER

Proportional Assist Ventilation will be used until patient is extubated.

Pressure Support Ventilation (PSV)

Pressure Support Ventilation on the PV840 ventilator will be used according to a weaning algorithm. If patients develop distress despite maximal level of support on PSV, they will be temporarily switched to assist-control mode.

Group Type: ACTIVE_COMPARATOR

PSV

Intervention Type: OTHER

Pressure Support Ventilation will be used until patient is extubated

Interventions

PSV

Pressure Support Ventilation will be used until patient is extubated

Intervention Type: OTHER

PAV

Proportional Assist Ventilation will be used until patient is extubated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 years or greater
• Mechanically ventilated patients who are ready to begin weaning according to prespecified eligibility criteria, and tolerate thirty minutes of pressure support ventilation (PSV), but are not ready for extubation, defined as an frequency to tidal volume (f/Vt) greater-than (>) 105 after two minutes of constant positive airway pressure (CPAP)
• Reason for intubation partially or completely reversed

Exclusion Criteria

• Tolerating PSV 5 greater-than (>)2 hrs (Weaned)
• Plan to extubate today
• Extubated today
• Considering Withdrawal of life support (less-than (<)48hrs)
• Neurosurgical patient
• High SC injury/ progressive NMD
• Tracheostomy at time of ICU admission
• Has met all weaning eligibility and been on Pressure Support Ventilation (PSV) >36 hours

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Karen Bosma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen J Bosma, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

PMID: 26807682 (View on PubMed)

Other Identifiers

13356

Identifier Type: OTHER

Identifier Source: secondary_id

R-07-237

Identifier Type: -

Identifier Source: org_study_id