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

NCT01666054 | Completed

• 2 other identifiers: R-07-23713356
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning From Mechanical Ventilation

Keywords

Weaning; mechanical ventilation; Proportional Assist Ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of weaning

  Duration of weaning will be assessed as (a) the time elapsed from study randomization until the patient successfully passes a spontaneous breathing trial, (b) time from randomization to successful extubation, and (c) number of ventilator-free days, defined as the number of days alive and free of mechanical ventilation during the 28 days post randomization. All patients enrolled in the study will be followed until discharge from ICU. A prior subgroup analysis is planned for patients with a high asynchrony index at baseline.

  From time of randomization up to 28 days

Secondary Outcomes (3)

• Change in asynchrony index from baseline

  Measurement of flow, airway pressure, and estimate of respiratory muscle pressure recorded at baseline then again, at high and at low levels of support during the first seven days of the weaning protocol

• Change in sedative drug administration from baseline

  Daily dose of sedative drugs administered at baseline and day 1, 3, and 7 of study protocol

• Delirium

  Up to 28 days post randomization

Other Outcomes (2)

• Tolerance of weaning mode

  Daily, up to 28 days post randomization

• Indication for increased ventilatory support

  Daily

Study Arms (2)

Proportional Assist Ventilation (PAV)

ACTIVE COMPARATOR

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.

Other: PAV

Pressure Support Ventilation (PSV)

ACTIVE COMPARATOR

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.

Other: PSV

Interventions

PSV OTHER

Pressure Support Ventilation will be used until patient is extubated

Pressure Support Ventilation (PSV)

PAV OTHER

Proportional Assist Ventilation will be used until patient is extubated.

Proportional Assist Ventilation (PAV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Medtronic - MITG: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (9)

• Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

  PMID: 11790214 BACKGROUND

• Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186.

  PMID: 9228375 BACKGROUND

• Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93. doi: 10.1164/ajrccm.158.2.9711045.

  PMID: 9700126 BACKGROUND

• Kollef MH, Shapiro SD, Silver P, St John RE, Prentice D, Sauer S, Ahrens TS, Shannon W, Baker-Clinkscale D. A randomized, controlled trial of protocol-directed versus physician-directed weaning from mechanical ventilation. Crit Care Med. 1997 Apr;25(4):567-74. doi: 10.1097/00003246-199704000-00004.

  PMID: 9142019 BACKGROUND

• Lellouche F, Mancebo J, Jolliet P, Roeseler J, Schortgen F, Dojat M, Cabello B, Bouadma L, Rodriguez P, Maggiore S, Reynaert M, Mersmann S, Brochard L. A multicenter randomized trial of computer-driven protocolized weaning from mechanical ventilation. Am J Respir Crit Care Med. 2006 Oct 15;174(8):894-900. doi: 10.1164/rccm.200511-1780OC. Epub 2006 Jul 13.

  PMID: 16840741 BACKGROUND

• Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.

  PMID: 8948561 BACKGROUND

• Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.

  PMID: 16896854 BACKGROUND

• Younes M. Proportional assist ventilation, a new approach to ventilatory support. Theory. Am Rev Respir Dis. 1992 Jan;145(1):114-20. doi: 10.1164/ajrccm/145.1.114.

  PMID: 1731573 BACKGROUND

• Bosma KJ, Read BA, Bahrgard Nikoo MJ, Jones PM, Priestap FA, Lewis JF. A Pilot Randomized Trial Comparing Weaning From Mechanical Ventilation on Pressure Support Versus Proportional Assist Ventilation. Crit Care Med. 2016 Jun;44(6):1098-108. doi: 10.1097/CCM.0000000000001600.

  PMID: 26807682 RESULT

Study Officials

• Karen J Bosma, MD, FRCPC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: July 1, 2013
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

CA (1)