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

NCT06344234 | Active Not Recruiting DMC

• 1 other identifier: 0049191
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease; Artificial Respiration

Keywords

noninvasive ventilation; respiration, artificial; Ventilators, Mechanical; Positive End-Expiratory Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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 DTF%

  24 hours

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

  24 hours

Other Outcomes (1)

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

  24 hours

Study Arms (1)

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.

Diagnostic Test: End-inspiratory Maneuvers

Interventions

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.

Also known as: End-Expiratory Occlusion Maneuvers, Esophageal pressure monitoring, Diaphragmatic ultrasounds

Cohort (n=60)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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% \[prot. n 1136947\]).

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Azienda ospedaliero-universitaria consorziale policlinico di Bari

Bari, Bari, 70124, Italy

Location

Related Publications (24)

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MeSH Terms

Conditions

Respiration Disorders; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Grasso, Prof

  Azienda Ospedaliero-Universitaria "Consorziale Policlinico" Bari

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: November 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)