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NCT Number: NCT06998927

Proportional Assist Ventilation Plus and Estimation of Respiratory Effort During the Transition to Spontaneous Ventilation

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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Británico de Buenos Aires

CABA, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Pre-existing esophageal balloon
  • Tolerates spontaneous modes >5 mins
  • Signed informed consent

Exclusion criteria

  • Meets extubation criteria
  • Hemodynamic instability
  • Psychomotor agitation (RASS >+1)
  • Bronchopleural fistula
  • Severe weakness (MRC <36)
  • Neuromuscular disease
  • Pregnancy

Treatment and study plan

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.

Primary outcomes

  1. Correlation Between Ventilator-Measured Work of Breathing Tool and and invasive respiratory effort markers

    Time frame: From enrollment to the end of measurents at 3 hours

    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.

Secondary outcomes

  1. Pocc (expiratory occlusion pressure in cmH₂O) during PAV+ analyzed across 3 assistance levels (20%/50%/70%) to validate ventilator-based effort monitoring.

    Time frame: From enrollment to the end of measurements at 3 hours

    Validate ventilator-measured WOB against Pocc (cmH₂O) in PAV+ measures compared at 20%/50%/70% assistance to assess non-invasive monitoring accuracy.

  2. 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.

    Time frame: From enrollment to the end of measurements at 3 hours

    Validate ventilator-measured WOB against P0.1 (cmH₂O) in PAV+ measures compared at 20%/50%/70% assistance to assess non-invasive monitoring accuracy.

Sponsors and collaborators

Lead sponsor

Argentinian Intensive Care Society

Other

Registry information

Official study title

Proportional Assist Ventilation Plus and Estimation of Respiratory Effort in Critically Ill Patients During the Transition to Spontaneous Ventilation: A Prospective Cohort Study

Acronym: PAV+ and WOB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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