Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE)
NCT ID: NCT06344234
Last Updated: 2026-01-12
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
60 participants
OBSERVATIONAL
2023-11-01
2026-06-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort (n=60)
All hypoxemic patients with a PaO2/FiO2 ratio equal or lower than 300, receiving post-extubation noninvasive ventilation.
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
* 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.
* 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.
End-inspiratory Maneuvers
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.
Interventions
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End-inspiratory Maneuvers
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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% \[prot. n 1136947\]).
18 Years
ALL
No
Sponsors
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University of Bari
OTHER
Responsible Party
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Salvatore Grasso
Professor
Principal Investigators
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Salvatore Grasso, Prof
Role: STUDY_CHAIR
Azienda Ospedaliero-Universitaria "Consorziale Policlinico" Bari
Locations
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Azienda ospedaliero-universitaria consorziale policlinico di Bari
Bari, Bari, Italy
Countries
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References
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Other Identifiers
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0049191
Identifier Type: -
Identifier Source: org_study_id
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