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

Recruiting

• Conditions: Respiratory Disease; Artificial Respiration
• Interventions: Diagnostic Test: End-inspiratory Maneuvers

• Registration Number: NCT06344234
• Lead Sponsor: University of Bari

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03
• Primary Completion: 2026-05-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 10%)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort (n=60)	End-inspiratory Maneuvers	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 PaO2/FiO2 ratio	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, ΔP, PMI and ΔPes	24 hours
Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%	24 hours

Trial Locations

Locations (1)

Azienda ospedaliero-universitaria consorziale policlinico di Bari; 🇮🇹 Bari, Italy