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Completed

NCT Number: NCT05576246

Airway Occlusion Measured During Non-invasive Ventilation to Assess Respiratory Effort

Non-invasive ventilation (NIV) is extensively used in critical care settings and emergency departments for a variety of aetiologies but specially for acute respiratory failure (ARF). It eliminates morbidity related to the endotracheal tube and use of sedatives so it reduces intensive care unit (ICU) complications; however, on the other hand, the harmful effects of spontaneous breathing through the intensity of inspiratory effort may predispose the patient to the onset of self-inflicted lung injury (SILI). Therefore, measuring the level of inspiratory effort is recommended.The aim of this proof-of-concept physiological study was to describe the correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Medical Group

Buenos Aires, 1636, Argentina

About this study

Non-invasive ventilation (NIV) is extensively used in critical care settings and emergency departments for a variety of aetiologies but specially for acute respiratory failure (ARF). Recommendations based on the GRADE methodology were addressed on several conditions such as exacerbation of chronic obstructive pulmonary disease (COPD), cardiogenic pulmonary oedema, de novo hypoxaemic respiratory failure, immunocompromised patients, chest trauma, palliative care, post-operative care, weaning and post-extubation period. NIV eliminates morbidity related to the endotracheal tube and use of sedatives so it reduces intensive care unit (ICU) acquired pneumonia, diaphragmatic atrophy, ICU acquired weakness and delirium. On the other hand, the harmful effects of spontaneous breathing through the intensity of inspiratory effort may follow a critical increase in respiratory drive, thus producing uncontrolled tidal change in dynamic transpulmonary pressure (PLdyn) that would increase the risk of injury to the dependent lung and predispose the patient to the onset of self-inflicted lung injury (SILI). High positive end-expiratory pressure (PEEP) renders spontaneous effort non injurious. P-SILI may worsen the clinical outcome of patients who require endotracheal intubation after having received noninvasive respiratory support. The underlying mechanisms of SILI are heterogeneous and include the pendelluft phenomenon, increased transvascular pressure gradient aggravating alveolar damage, excessive diaphragmatic loading with impaired systemic oxygen delivery and muscle injury. Therefore, measuring the level of inspiratory effort is recommended.

Esophageal manometry is a precise estimate of the changes in pleural pressure and is considered the gold standard to measure respiratory effort. Tonelli et al. measured tidal change in esophageal pressure (ΔPes) in patients with acute hypoxic de novo respiratory failure on NIV and demonstrated a median baseline value of ΔPes of 34 cmH2O that was significantly reduced within the first 2 hours of ventilation in patients who were successful in the NIV trial, whereas those failing the NIV trial did not show a significant reduction. However, esophageal manometry is rarely available bedside in acute settings on severe patients with respiratory distress so other ways of measuring inspiratory effort have been assessed, such as nasal pressure swings or the patient's respiratory effort against the occluded airway (ΔPocc). The latest was demonstrated on invasive mechanical ventilation patients. Lopez Navas et al. tried to correlate the inspiratory pressure-time product (PTPinsp) from transdiaphragmatic pressure to a novel expiratory occlusion method of 0.2 s in healthy volunteers with NIV on different settings; however, their results through Bland-Altman analysis of PTPinsp revealed mean differences between -4.22 and 7.57 cmH2O (SD 0.77- 8.52) and considerable differences between subjects. Moreover, Dargent A, et al. explored the feasibility of a noninvasive respiratory drive evaluation using ventilator-derived data as P0.1, clinical information and diaphragm ultrasound in COVID 19 patients on CPAP session with 5 cmH2O. They showed that P0.1 was achievable during NIV with a median value of 4.4 [2.7-5.1] cmH2O and not correlated with leaks, though they were small (5 [4-7] l/min); nevertheless, P0.1 was not accurate at predicting the risk of intubation but it was limited by its small sample size. In addition, P0.1 has been previously evaluated (with other physiological parameters) on NIV in COPD patients to predict post-extubation respiratory distress. They reported that only P0.1 recorded 1 h after the discontinuation of mechanical ventilation followed by 30 minutes of 4 cmH2O pressure support ventilation, was significantly different between the patients with and without respiratory distress (4.2 vs 1.8, p < 0.01). Nonetheless, there are no studies that measured bedside the pressure generated by the respiratory muscles during NIV.

The aim of this proof-of-concept physiological study was to describe the correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy subjects over 18 years old who wish to participate were included.

Exclusion criteria

  • Exclusion criteria was the presence of any esophageal disease or COPD.

Treatment and study plan

airway pressure occlusion measurement

Diagnostic Test

Flow, airway pressure (Paw), and esophageal pressure (Pes) will be recorded for 10 minutes on different NIV settings: during each one, three end-expiratory airway occlusions will be applied at random intervals. Each occlusion was maintained for the duration of a single breath deflection in Paw from PEEP, confirmed by the return of Paw to baseline.

Primary outcomes

  1. correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

    Time frame: The subjects will be measured on each ventilator setting (3 settings) for 10 minutes

    Evaluate the agreement between ΔPocc and ΔPes in occluded breaths

Secondary outcomes

  1. Correlation between Pccvent and PTPmus

    Time frame: The subjects will be measured on each ventilator setting (3 settings) for 10 minutes.

    The secondary outcome was the correlation between ΔPoccvent the mean PTPmus during the last minute of ventilation for each ventilator setting.

  2. Correlation between Poccvent and Pesflux

    Time frame: The subjects will be measured on each ventilator setting (3 settings) for 10 minutes.

    Evaluate the agreement between ΔPocc and ΔPes in occluded breaths

    Evaluate the agreement between ΔPocc and ΔPes in non-occluded breaths

    Evaluate this relationship considering leak

    Evaluate the agreement between ΔPocc and PTPmin

Sponsors and collaborators

Lead sponsor

Clinica Olivos SMG

Other

Collaborators

  • Hospital Nacional Profesor Alejandro Posadas

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Oct 12, 2022
Registry last updated
Sep 26, 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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