Respiratory EffortPAV+ and WOBNCT06998927
Proportional Assist Ventilation Plus and Estimation of Respiratory Effort During the Transition to Spontaneous Ventilation
An observational study of Respiratory Effort and Proportional Assist Ventilation, run by Argentinian Intensive Care Society at 1 site in Argentina.
Trial summary
In intensive care units, many critically ill patients need help from a machine called a ventilator to breathe. Once these patients start to recover, doctors try to gradually reduce this support and help them breathe on their own again. However, not all patients are ready to be taken off the ventilator right away. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Effort, Proportional Assist Ventilation, Work of Breathing
- What is being tested?
- Application of Proportional Assist Ventilation Plus (PAV+) at three support levels (20%, 50%, 70%) to assess ventilator-displayed work of breathing and its correlation with physiologic measures.
- How many people
- 35 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Feb 2024to 30 Jun 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective cohort study will enroll critically ill adults (>18years) requiring prolonged mechanical ventilation (>48 hours) at Hospital Británico de Buenos Aires' ICU. Participants represent a diverse urban population with complex respiratory failures (post-operative, pneumonia, ARDS, COPD or chronic cardiopulmonary exacerbations) transitioning to spontaneous breathing. The ICU, staffed by PAV+-trained specialists and equipped with Puritan Bennett™ ventilators/FluxMed® monitoring, provides a representative Latin American setting for studying challenging weaning cases.
Who may be able to join
- Adults (>18 yrs) requiring invasive MV >48 hrs
- Meeting spontaneous breathing transition criteria:
- Hemodynamic stability (NE <0.1 μg/kg/min)
- Spontaneous breathing efforts
- RASS -2 to +1
- FiO₂ <50% or PaO₂ >60mmHg with PEEP ≤10cmH₂O
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- Pre-existing esophageal balloon
- Tolerates spontaneous modes >5 mins
- Signed informed consent
Who cannot join
- Meets extubation criteria
- Hemodynamic instability
- Psychomotor agitation (RASS >+1)
- Bronchopleural fistula
- Severe weakness (MRC <36)
- Neuromuscular disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proportional Assist Ventilation Plus and Estimation of Respiratory Effort in Critically Ill Patients During the Transition to Spontaneous Ventilation: A Prospective Cohort Study
In intensive care units, many critically ill patients need help from a machine called a ventilator to breathe. Once these patients start to recover, doctors try to gradually reduce this support and help them breathe on their own again. However, not all patients are ready to be taken off the ventilator right away. During this transition, it's important to find the right amount of help-enough to support their breathing, but not so much that the machine does all the work for them.
This study focuses on a special type of ventilator setting called Proportional Assist Ventilation Plus (PAV+). Unlike traditional modes, which give a fixed level of support, PAV+ adjusts the amount of help it gives based on how hard the patient is trying to breathe. The more effort a patient makes, the more support the machine provides-and vice versa. This can make breathing feel more natural and may protect the lungs and breathing muscles during recovery.
Read more
Modern ventilators also display a measurement called "Work of Breathing," which tells how much effort the patient is using to breathe. This study wants to find out whether this measurement from the ventilator is a reliable way to monitor a patient's breathing effort, compared to other more invasive or complex methods.
The research will include 20 adult patients who are recovering in the ICU and have been on mechanical ventilation for more than 48 hours. All patients will have already met some criteria showing they're ready to begin breathing more on their own, but are not quite ready to have the breathing tube removed.
Each patient will go through different levels of PAV+ support, and researchers will record how much effort they make to breathe using several methods, including special pressure sensors and data from the ventilator.
The goal of the study is to better understand how to measure breathing effort safely and easily, and to improve how we support patients as they recover the ability to breathe on their own. If successful, this could help reduce complications and improve recovery for people on ventilators.
There are no added risks or costs for the patients involved. All equipment used in the study is already part of regular ICU care. Participation requires informed consent and the privacy of all participants will be fully protected.
- Being tested
- Application of Proportional Assist Ventilation Plus (PAV+) at three support levels (20%, 50%, 70%) to assess ventilator-displayed work of breathing and its correlation with physiologic measures.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Proportional Assist Ventilation Plus (PAV+) at three support levels (20%, 50%, 70%) to assess ventilator-displayed work of breathing and its correlation with physiologic measures.Other
This intervention is distinguished by applying Proportional Assist Ventilation Plus (PAV+) at three support levels (20%, 50%, 70%) within the same patient, allowing a stepwise analysis of its effect on work of breathing. It uses real-time ventilator-displayed work of breathing, a noninvasive and underexplored tool, correlated with multiple physiological parameters such as esophageal pressure, Pocc, and P0.1. This within-subject design controls for interindividual variability, improving the precision of the analysis. Focusing on patients with spontaneous respiratory effort facilitates clinical application to optimize personalized ventilatory support. Thus, the study provides novel data to adjust support levels according to the patient's actual effort and to validate ventilator measurements against reference physiological indicators.
| Study group | Role | What they receive |
|---|---|---|
| critically ill patients during the transition from controlled mechanical ventilation to spontaneous | Not described Receives: Other: Application of Proportional Assist Ventilation Plus (PAV+) at three support levels (20%, 50%, 70%) to assess ventilator-displayed work of breathing and its correlation with physiologic measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Ventilator-Measured Work of Breathing Tool and and invasive respiratory effort markers
Correlation between non-invasive WOB (measured by Puritan Bennett™ ventilators tool) and invasive metrics (Pes/PTPes via esophageal catheter, in cmH₂O and cmH₂O·s) during PAV+. Analyzed across 3 assistance levels (20%/50%/70%) to validate ventilator-based effort monitoring.
Measured: From enrollment to the end of measurents at 3 hours
Secondary outcomes (2)
Pocc (expiratory occlusion pressure in cmH₂O) during PAV+ analyzed across 3 assistance levels (20%/50%/70%) to validate ventilator-based effort monitoring.
Validate ventilator-measured WOB against Pocc (cmH₂O) in PAV+ measures compared at 20%/50%/70% assistance to assess non-invasive monitoring accuracy.
Measured: From enrollment to the end of measurements at 3 hours
P0.1 (inspiratory occlusion pressure at 100 mseg in cmH₂O) during PAV+ analyzed across 3 assistance levels (20%/50%/70%) to validate ventilator-based effort monitoring.
Validate ventilator-measured WOB against P0.1 (cmH₂O) in PAV+ measures compared at 20%/50%/70% assistance to assess non-invasive monitoring accuracy.
Measured: From enrollment to the end of measurements at 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Feb 2024
- Primary completion21 May 2025
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Respiratory EffortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Argentinian Intensive Care Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Plotnikow, Argentinian Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998927
- Sponsor's protocol ID
- CRIHB 12048
- Acronym
- PAV+ and WOB
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arellano DH, Brito R, Morais CCA, Ruiz-Rudolph P, Gajardo AIJ, Guinez DV, Lazo MT, Ramirez I, Rojas VA, Cerda MA, Medel JN, Illanes V, Estuardo NR, Bruhn AR, Brochard LJ, Amato MBP, Cornejo RA. Pendelluft in hypoxemic patients resuming spontaneous breathing: proportional modes versus pressure support ventilation. Ann Intensive Care. 2023 Dec 20;13(1):131. doi: 10.1186/s13613-023-01230-w.
PubMed 38117367Spinazzola G, Ferrone G, Costa R, Festa O, Piastra M, Bello G, Amato MF, Rossi M, Conti G. "Evaluation of Different Inspiratory Efforts in a Pediatric Model of Healthy Lung and Pediatric Acute Respiratory Distress Syndrome During Optimized Pressure Support Ventilation and Proportional Assist Ventilation Plus (PAV+): A Bench Study. Pediatr Pulmonol. 2025 Mar;60(3):e71027. doi: 10.1002/ppul.71027.
PubMed 40042134Gerson EAM, Dominelli PB, Leahy MG, Kipp S, Guenette JA, Archiza B, Sheel AW. The effect of proportional assist ventilation on the electrical activity of the human diaphragm during exercise. Exp Physiol. 2023 Feb;108(2):296-306. doi: 10.1113/EP090808. Epub 2022 Nov 24.
PubMed 36420595Fazio SA, Lin G, Cortes-Puch I, Stocking JC, Tokeshi B, Kuhn BT, Adams JY, Harper R. Work of Breathing During Proportional Assist Ventilation as a Predictor of Extubation Failure. Respir Care. 2023 Aug;68(8):1049-1057. doi: 10.4187/respcare.10225. Epub 2023 May 9.
PubMed 37160340Amargiannitakis V, Gialamas I, Pediaditis E, Soundoulounaki S, Prinianakis G, Vaporidi K, Akoumianaki E, Proklou A, Alexopoulou C, Georgopoulos D, Kondili E. Validation of a Proposed Algorithm for Assistance Titration During Proportional Assist Ventilation With Load-Adjustable Gain Factors. Respir Care. 2020 Jan;65(1):36-44. doi: 10.4187/respcare.06988. Epub 2019 Sep 17.
PubMed 31530626Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.
PubMed 31694692de Vries HJ, Tuinman PR, Jonkman AH, Liu L, Qiu H, Girbes ARJ, Zhang Y, de Man AME, de Grooth HJ, Heunks L. Performance of Noninvasive Airway Occlusion Maneuvers to Assess Lung Stress and Diaphragm Effort in Mechanically Ventilated Critically Ill Patients. Anesthesiology. 2023 Mar 1;138(3):274-288. doi: 10.1097/ALN.0000000000004467.
PubMed 36520507Sassoon CS, Light RW, Lodia R, Sieck GC, Mahutte CK. Pressure-time product during continuous positive airway pressure, pressure support ventilation, and T-piece during weaning from mechanical ventilation. Am Rev Respir Dis. 1991 Mar;143(3):469-75. doi: 10.1164/ajrccm/143.3.469.
PubMed 2001053Charlson ME, Charlson RE, Peterson JC, Marinopoulos SS, Briggs WM, Hollenberg JP. The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients. J Clin Epidemiol. 2008 Dec;61(12):1234-1240. doi: 10.1016/j.jclinepi.2008.01.006. Epub 2008 Jul 10.
PubMed 18619805Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
PubMed 8844239Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.
PubMed 7149443Hermans G, Clerckx B, Vanhullebusch T, Segers J, Vanpee G, Robbeets C, Casaer MP, Wouters P, Gosselink R, Van Den Berghe G. Interobserver agreement of Medical Research Council sum-score and handgrip strength in the intensive care unit. Muscle Nerve. 2012 Jan;45(1):18-25. doi: 10.1002/mus.22219.
PubMed 22190301Beloncle F, Akoumianaki E, Rittayamai N, Lyazidi A, Brochard L. Accuracy of delivered airway pressure and work of breathing estimation during proportional assist ventilation: a bench study. Ann Intensive Care. 2016 Dec;6(1):30. doi: 10.1186/s13613-016-0131-y. Epub 2016 Apr 14.
PubMed 27076185Vaporidi K, Psarologakis C, Proklou A, Pediaditis E, Akoumianaki E, Koutsiana E, Chytas A, Chouvarda I, Kondili E, Georgopoulos D. Driving pressure during proportional assist ventilation: an observational study. Ann Intensive Care. 2019 Jan 3;9(1):1. doi: 10.1186/s13613-018-0477-4.
PubMed 30603960Akoumianaki E, Prinianakis G, Kondili E, Malliotakis P, Georgopoulos D. Physiologic comparison of neurally adjusted ventilator assist, proportional assist and pressure support ventilation in critically ill patients. Respir Physiol Neurobiol. 2014 Nov 1;203:82-9. doi: 10.1016/j.resp.2014.08.012. Epub 2014 Aug 26.
PubMed 25169117