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NCT Number: NCT06344234

Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE)

The goal of this observational study is to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.

The main questions this trial aims to answer are:

- Primary Outcome: whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.

Secondary outcomes will include:

* Statistic metric of association between P0.1, ΔP, PMI and ΔPes * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF% * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF% * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort.

Participants will undergo the following tasks and treatments:

* Complete written informed consent before enrollment. * Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks. * Monitoring of esophageal pressure (in all patients the catheter will be placed before extubation, according to clinical judgment, and its correct position will be verified through a positive pressure occlusion test) * Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer. * Sudden end-inspiratory and end-expiratory occlusion maneuvers, to measure plateau pressure (Pplat) and end-expiratory airway occlusion pressure (ΔPocc), respectively. * Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS). * Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Respiratory Disease Artificial Respiration Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda ospedaliero-universitaria consorziale policlinico di Bari

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater than or equal to 18 years.
  • Non-pregnant and non-lactating.
  • Monitored through esophageal pressure for clinical decision before extubation.
  • Able to provide written informed consent to participate in the study.

Exclusion criteria

  • Patients with severe facial trauma or deformity that precludes the placement of a facemask or esophageal catheter.
  • Patients with neuromuscular disorders that may impair inspiratory drive and effort.
  • Patients with acute exacerbation of COPD
  • Patients with esophageal or tracheal abnormalities that impede esophageal manometry.
  • Patients with a known hypersensitivity or allergy to any of the materials used in the study.
  • Excessive air leak (difference between inspiratory and expiratory tidal volume major or equal to 30% [prot. n 1136947]).

Treatment and study plan

End-inspiratory Maneuvers

Diagnostic Test

Airway pressure, flow, and esophageal pressure will be continuously recorded in all patients using a dedicated pneumotachograph and pressure transducer: all signals will be acquired and stored. Once a stable ventilation pattern is observed NIV will be administered by setting ventilator in invasive-pressure support ventilation. PEEP and PS-level will by kept constant while expiratory trigger will be adjusted to optimize patient-ventilatory synchrony. Immediately after, sudden end-inspiratory and end-expiratory occlusion maneuvers will be performed to measure plateau pressure and end-expiratory airway occlusion pressure (ΔPocc), respectively. Invasive PSV will be used only to perform the occlusion maneuvers, subsequently, PSV will be delivered in non-invasive PSV mode. Patient's blood-gas parameters and vital signs will be collected, including discomfort assessment. During the occlusion maneuvers, diaphragm ultrasound will be performed, and images will be recorded.

Other names: End-Expiratory Occlusion Maneuvers, Esophageal pressure monitoring, Diaphragmatic ultrasounds

Primary outcomes

  1. Statistic metric of association between ΔPocc and ΔPes

    Time frame: 24 hours

    to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure

Secondary outcomes

  1. Statistic metric of association between P0.1, ΔP, PMI and ΔPes

    Time frame: 24 hours

  2. Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio

    Time frame: 24 hours

  3. Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume

    Time frame: 24 hours

  4. Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%

    Time frame: 24 hours

  5. Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%

    Time frame: 24 hours

  6. Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort

    Time frame: 24 hours

Other outcomes

  1. Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV

    Time frame: 24 hours

    To investigate the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

Noninvasive Assessment of Inspiratory Effort and Tidal Distension During Noninvasive Ventilation. The INSPIRE Study.

Acronym: INSPIRE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Jan 12, 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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