protocolSection identificationModule nctId: NCT06344234, orgStudyIdInfo id: 0049191, briefTitle: Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE), acronym: INSPIRE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Bari, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Respiratory Disease, conditions: Artificial Respiration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: End-inspiratory Maneuvers, outcomesModule primaryOutcomes measure: Statistic metric of association between ΔPocc and ΔPes, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔP, PMI and ΔPes, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort, otherOutcomes measure: Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda ospedaliero-universitaria consorziale policlinico di Bari, status: RECRUITING, city: Bari, zip: 70124, country: Italy, contacts name: Salvatore Grasso, MD, Professor, role: CONTACT, email: salvatore.grasso@uniba.it, contacts name: Francesco Murgolo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Domenico Luca Grieco, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.11148, lon: 16.8554, hasResults: False