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

Lawson Health Research Institute

Status: Completed

Conditions: Weaning From Mechanical Ventilation

Treatments: Other: PSV; Other: PAV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01666054

R-07-237

13356 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Proportional Assist Ventilation (PAV)

Active Comparator group

Description:

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.

Treatment:

Other: PAV

Pressure Support Ventilation (PSV)

Active Comparator group

Description:

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.

Treatment:

Other: PSV