Artificial Respiration, Respiratory Disease
Conditions
Keywords
noninvasive ventilation, respiration, artificial, Ventilators, Mechanical, Positive End-Expiratory Pressure
Brief summary
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.
Interventions
DIAGNOSTIC_TESTEnd-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.
Sponsors
University of Bari
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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% \[prot. n 1136947\]).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statistic metric of association between ΔPocc and ΔPes | 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
| Measure | 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 |
| 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 Ex/DTF% | 24 hours |
| Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort | 24 hours |
| Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF% | 24 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV | 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 |
Countries
Italy
Outcome results
None listed