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NCT Number: NCT04524091

Prediction of Inspiratory Effort Response to High PEEP in Patients Recovering From ARDS

Spontaneous breathing during the transition from controlled to assisted ventilation in ARDS may be harmful, as high respiratory drive can generate large transpulmonary pressure swings and worsen lung injury. Higher PEEP may mitigate this by reducing inspiratory effort and lung stress, but patient response is variable and difficult to predict. While improved lung compliance appears to mediate the protective effects of PEEP, its bedside assessment is complex. Preclinical data suggest that changes in compliance are inversely reflected by changes in respiratory rate, but this relationship and its clinical utility in ARDS patients remain unclear.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanatorio Anchorena de San Martin

San Martín, Buenos Aires, B1650CQU, Argentina

Location status: Recruiting

Location contact

Joaquin Perez, PT

CONTACT

[email protected]

About this study

Spontaneous Breathing (SB) can be potentially harmful in patient with Acute Respiratory Distress Syndrome (ARDS) during the transition phase of passive ventilation to partial ventilatory support. A high respiratory drive and consequently, a strong inspiratory effort, may produce large transpulmonary pressure (TP) swings mainly in dependent lung regions closer to the diaphragm and cause alveolar rupture and inflammatory mediators release.

The application of high Positive End Expiratory Pressure (PEEP) during SB has shown to ameliorate the progression of lung injury by decreasing the TP and esophageal pressure (EP) swings and the stress / strain applied to the lung. However, it is uncertain which patient will respond adequately to the application of high PEEP and consequently will reduce the inspiratory effort.

Recent evidence suggests that high PEEP may confer protective effects when lung compliance improves. However, assessing lung compliance at the bedside is challenging, as it requires esophageal pressure monitoring. Simpler tools to identify lung compliance response to PEEP are neccesary.

Preclinical data suggest that the changes in compliance are followed by opposite changes in respiratory rate (RR) - i.e., if compliance improves, RR decreases and vicerversa. However, if this behaviour is also observed in ARDS patients ventilated at different PEEP levels is unkown. Additionally, whether changes in RR can be useful to identify changes in lung compliance when increasing PEEP has never been tested.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Need of invasive mechanical ventilation
  • Patients who had fulfill ARDS criteria based on Berlin definition during any time of invasive mechanical ventilation.
  • Patient ventilated in pressure support ventilation.
  • Time of invasive ventilation expected to be longer than 24 hs after the day of enrollment.

Exclusion criteria

  • Neuromuscular diseases (e.g., amyotrophic lateral sclerosis, Duchenne Erb)
  • previous diagnosis of chronic obstructed pulmonary disease
  • not resolved pneumothorax
  • bronchopleural fistula
  • suspicion of central respiratory drive alteration (e.g., benzodiazepines intoxication).

Treatment and study plan

Positive end expiratory pressure

Other

Initially, the patients will be ventilated using pressure support ventilation with an inspiratory pressure adjusted to achieve 6 - 8 ml/kg of PBW with a minimal esophageal pressure swing of 5 cmH2O and a PEEP of 5 cmH2O. After 5 minutes, we will collect basic and advanced respiratory monitoring, including esophageal pressure and transpulmonary pressure swings. The same procedure will be carried out with 10 and 15 cmH2O of PEEP. Inspiratory pressure will be kept constant throughout the protocol.

Primary outcomes

  1. Lung compliance response

    Time frame: 10 minutes

    changes in lung compliance from one PEEP level to the subsequent higher level, expressed in percentage of change

Secondary outcomes

  1. Esophageal pressure swing

    Time frame: 10 minutes

    Esophageal pressure swing will be calculated as the difference between end expiration and end inspiration esophageal pressure during the las 30-60 seconds of each PEEP condition evaluated

  2. Dynamic transpulmonary pressure swing

    Time frame: 10 minutes

    Dynamic transpulmonary pressure swing will be calculated as the difference between end expiration and end inspiration dynamic transpulmonary pressure during the las 30-60 seconds of each PEEP condition evaluated

  3. Respiratory rate response

    Time frame: 10 minutes

    changes in respiratory rate from one PEEP level to the subsequent higher level, expressed in percentage of change

Study contacts

Contact information is provided by the study sponsor or research team.

Javier H Dorado, PT

CONTACT

[email protected]

+54 1141644262

Joaquin Pérez, PT

CONTACT

[email protected]

+542245505907

Sponsors and collaborators

Lead sponsor

Sanatorio Anchorena San Martin

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2020
Registry last updated
Apr 16, 2026

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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