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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:
Participants will undergo the following tasks and treatments:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Statistic metric of association between ΔPocc and ΔPes | to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Statistic metric of association between P0.1, ΔP, PMI and ΔPes | 24 hours | |
| Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio | 24 hours | |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV | 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 | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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All hypoxemic patients with a PaO2/FiO2 ratio equal or lower than 300, receiving post-extubation noninvasive ventilation via an nose-to-mouth or a full-face mask, will be screened for eligibility.
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Grasso, Prof | Azienda Ospedaliero-Universitaria "Consorziale Policlinico" Bari | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda ospedaliero-universitaria consorziale policlinico di Bari | Bari | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33764378 | Background | Grieco DL, Menga LS, Cesarano M, Rosa T, Spadaro S, Bitondo MM, Montomoli J, Falo G, Tonetti T, Cutuli SL, Pintaudi G, Tanzarella ES, Piervincenzi E, Bongiovanni F, Dell'Anna AM, Delle Cese L, Berardi C, Carelli S, Bocci MG, Montini L, Bello G, Natalini D, De Pascale G, Velardo M, Volta CA, Ranieri VM, Conti G, Maggiore SM, Antonelli M; COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1731-1743. doi: 10.1001/jama.2021.4682. | |
| 37326646 |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume |
| 24 hours |
| Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF% | 24 hours |
| Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF% | 24 hours |
| Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort | 24 hours |
| Background |
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