NCT02447692

Brief Summary

For adult patients with acute respiratory failure requiring invasive mechanical ventilation, does a ventilation strategy using proportional assist ventilation with load-adjustable gain factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a ventilation strategy using pressure support ventilation (PSV)?

Trial Health

93
On Track

Trial Health Score

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

Enrollment
575

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
7 countries

22 active sites

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

First Submitted

Initial submission to the registry

May 8, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2024

Completed
Last Updated

May 22, 2025

Status Verified

August 1, 2024

Enrollment Period

7.8 years

First QC Date

May 8, 2015

Last Update Submit

May 16, 2025

Conditions

Critically IllAcute Respiratory Failure

Keywords

Proportional Assist VentilationPressure Support VentilationWeaning

Outcome Measures

Primary Outcomes (1)

  • Time from randomization to successful liberation from invasive mechanical ventilation.

    "Successful liberation" is defined as removal of the endotracheal tube AND remaining alive with no need for reintubation/reinstitution of invasive mechanical ventilation for 7 days post extubation, or until successful ICU discharge, or until live hospital discharge, whichever comes first.

    up to 90 days

Secondary Outcomes (9)

  • Ventilator-free days at 14, 21 and 28 days post randomization

    14, 21 and 28 days post randomization

  • Time from randomization to live ICU discharge (up to day 90)

    up to 90 days

  • Time from randomization to live hospital discharge (up to day 90)

    up to 90 days

  • Mortality

    up to 90 days

  • Weaning Progress

    up to 90 days

  • +4 more secondary outcomes

Other Outcomes (7)

  • Co-interventions

    28 days

  • Subgroup analyses based on: (a) duration of MV prior to randomization as a continuous variable or as a binary variable of greater than 5 days

    At randomization

  • Subgroup analyses based on (b) failing an SBT prior to randomization vs. failed CPAP 0 trial vs. failed weaning criteria prior to randomization

    At randomization

  • +4 more other outcomes

Study Arms (2)

PSV ventilation strategy

ACTIVE COMPARATOR

The control is the standard of care PSV ventilation strategy, designed to adjust the level of support according to usual clinical parameters.

Other: PSV ventilation strategy

PAV+ ventilation strategy

ACTIVE COMPARATOR

The intervention is a PAV+ ventilation strategy, designed to adjust the level of support (gain) to target a predefined range of respiratory muscle pressure.

Other: PAV+ ventilation strategy

Interventions

PSV ventilation strategyOTHER

An algorithm for adjusting the level of pressure support according to usual clinical parameters; patients not tolerating PSV will be switched to Assist/Control mode according to predefined criteria

PSV ventilation strategy
PAV+ ventilation strategyOTHER

An algorithm for adjusting the level of support (gain) to maintain a predefined range of respiratory muscle pressure; patients not tolerating PAV+ (Puritan Bennett™ 840 or 980 ventilator) will be switched to Assist/Control mode according to predefined criteria

PAV+ ventilation strategy

Eligibility Criteria

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

You may not qualify if:

  • A1. Age 18 years or older
  • A2. Intubated and receiving any mode of invasive mechanical ventilation ≥ 24 hours
  • A3. Anticipating withdrawal of life support and/or shift to palliation as the goal of care
  • A4. Severe central neurologic disorder (eg. Hemorrhage, stroke, tumour) causing elevated intracranial pressure, or impaired control of breathing, or requiring specific ventilator adjustments (i.e. To attain specific CO2 target) or requiring neurosurgical intervention
  • A6. Severe COPD: Baseline daytime hypercapnia (pCO2\> 50 mmHg) OR GOLD 4 airflow limitation (FEV1\<30% predicted) OR MRC class 4 symptoms ("I am too breathless to leave the house" OR "I am breathless when dressing")
  • A7. Broncho-pleural fistula
  • A8. Tracheostomy present at ICU admission for the purpose of chronic or prolonged mechanical ventilation (\>21 days). (Note that a patient who was endotracheally intubated for acute respiratory failure and received a tracheostomy during their ICU admission, prior to enrolment, is not excluded under A8).
  • A9. Current enrolment in a confounding study, as assessed by the steering committee
  • A10. Previous randomization in the PROMIZING Study
  • A11. Severe, end-stage, irreversible respiratory or cardiac disease (e.g. interstitial lung disease, pulmonary fibrosis, cardiomyopathy, valvulopathy) likely to result in prolonged or chronic ventilator dependence /unlikely to wean from mechanical ventilation \[Note: patients who are candidates for intervention to treat the underlying respiratory/cardiac disease (e.g. lung transplant, heart transplant, cardiac surgery) may be re-evaluated once intervention is complete and they no longer meet criteria A11.\]
  • B1. Ability or potential ability to trigger ventilator breaths (i.e. not receiving neuromuscular blockade).
  • B2. On Assist/Control volume-cycled ventilation: Technically satisfactory plateau pressure ≤ 30 cm H2O (see Operations Manual) OR On Assist/Control pressure-controlled ventilation or similar mode: Pressure control plus PEEP ≤ 30 cm H2O OR On Pressure Support ventilation: Pressure support plus PEEP ≤ 30 cm H2O OR On Proportional Assist ventilation: PAV gain \<85%
  • B3. PaO2 ≥ 60 mmHg or SpO2 ≥ 90% on FiO2 ≤ 0.60 and PEEP ≤ 15 cm H2O
  • B4. Metabolic disorders corrected: pH ≥7.32
  • B5. Stable hemodynamic status: stable or decreasing doses of vasopressors for ≥6 hours
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"

Buenos Aires, C1430EFA, Argentina

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Victoria Hospital

London, Ontario, Canada

Location

Sunnybrook Hospital - Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

North York General Hospital

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

UHN- Toronto General Hospital

Toronto, Ontario, Canada

Location

UHN- Toronto Western Hospital

Toronto, Ontario, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, GC6R+GW, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

Institut Universitaire de cardiologie et de pneumologie de Quebec

Québec, Quebec, Canada

Location

Centre Hospitalier Universitaire (CHU) de Angers

Angers, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, QFW8+H5, France

Location

Hôpital Henri Mondor (Assistance Publique-Hôpitaux de Paris)

Créteil, France

Location

Hôpital Universitaire Pitié-Salpêtrière

Paris, France

Location

Centre Hospitalier Universitaire (CHU) de Rouen

Rouen, France

Location

University Hospital of Heraklion

Heraklion, Greece

Location

University Hospital of Ferrara

Ferrara, Italy

Location

San Giovanni Battista University Hospital

Turin, Italy

Location

King Abdulaziz Medical City

Riyadh, 11426, Saudi Arabia

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Related Publications (3)

  • Bosma KJ, Burns KEA, Martin CM, Skrobik Y, Mancebo Cortes J, Mulligan S, Lafreniere-Roula M, Thorpe KE, Suarez Montero JC, Moran Chorro I, Rodriguez-Farre N, Butler R, Bentall T, Beduneau G, Enguerrand P, Santos M, Piraino T, Spadaro S, Montanaro F, Basmaji J, Campbell E, Mercat A, Beloncle FM, Carteaux G, Maraffi T, Charbonney E, Lecronier M, Dres M, Arabi YM, Amaral ACK, Marinoff N, Adhikari NKJ, Geagea A, Shin P, Vaporidi K, Kondili E, Shahin J, Campisi J, Rodriguez PO, Setten M, Goligher EC, Ferguson ND, Fanelli V, Ferreyra G, Lellouche F, Sibley S, Brochard L; PROMIZING Study Investigators, the Canadian Critical Care Trials Group, and the REVA Network. Proportional-Assist Ventilation for Minimizing the Duration of Mechanical Ventilation. N Engl J Med. 2025 Sep 18;393(11):1088-1103. doi: 10.1056/NEJMoa2505708. Epub 2025 Jun 13.

    PMID: 40513024DERIVED

  • Bosma KJ, Lafreniere-Roula M, Jiang A, Heath A, Ouyang Y, Wade K, Hu P, Burns KEA, Martin CM, Skrobik Y, Mulligan S, Thorpe KE, Brochard L; members of the Canadian Critical Care Trials Group and the REVA Network. Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial. Trials. 2024 Dec 30;25(1):855. doi: 10.1186/s13063-024-08669-7.

    PMID: 39736673DERIVED

  • Bosma KJ, Martin CM, Burns KEA, Mancebo Cortes J, Suarez Montero JC, Skrobik Y, Thorpe KE, Amaral ACK, Arabi Y, Basmaji J, Beduneau G, Beloncle F, Carteaux G, Charbonney E, Demoule A, Dres M, Fanelli V, Geagea A, Goligher E, Lellouche F, Maraffi T, Mercat A, Rodriguez PO, Shahin J, Sibley S, Spadaro S, Vaporidi K, Wilcox ME, Brochard L; Canadian Critical Care Trials Group and; REVA Network. Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study. Trials. 2023 Mar 27;24(1):232. doi: 10.1186/s13063-023-07163-w.

    PMID: 36973743DERIVED

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karen J Bosma

    London Health Sciences Centre, London, Ontario, Canada

    PRINCIPAL INVESTIGATOR

  • Laurent Brochard

    St. Michael's Hospital, Toronto, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 19, 2015

Study Start

September 14, 2016

Primary Completion

July 16, 2024

Study Completion

July 16, 2024

Last Updated

May 22, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Data will be collected electronically and stored at the Clinical Coordinating Center at the Applied Health Research Centre (AHRC). A de-identified database of all data may be made available for use 3 years after the primary publication upon request and review of the statistical analysis plan by the PROMIZING steering committee.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
3 years after the primary publication

Locations

AR(1)SA(1)ES(1)FR(5)CA(11)GR(1)IT(2)