Airway Occlusion Measured During Non-invasive Ventilation to Assess Respiratory Effort

NCT05576246 | Completed

• 1 other identifier: Airway occlusion V1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive ventilation (NIV) is extensively used in critical care settings and emergency departments for a variety of aetiologies but specially for acute respiratory failure (ARF). It eliminates morbidity related to the endotracheal tube and use of sedatives so it reduces intensive care unit (ICU) complications; however, on the other hand, the harmful effects of spontaneous breathing through the intensity of inspiratory effort may predispose the patient to the onset of self-inflicted lung injury (SILI). Therefore, measuring the level of inspiratory effort is recommended.The aim of this proof-of-concept physiological study was to describe the correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

Conditions

Healthy Volunteers

Keywords

non invasive ventilation; occlusion airway pressure

Outcome Measures

Primary Outcomes (1)

• correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

  Evaluate the agreement between ΔPocc and ΔPes in occluded breaths

  The subjects will be measured on each ventilator setting (3 settings) for 10 minutes

Secondary Outcomes (2)

• Correlation between Pccvent and PTPmus

  The subjects will be measured on each ventilator setting (3 settings) for 10 minutes.

• Correlation between Poccvent and Pesflux

  The subjects will be measured on each ventilator setting (3 settings) for 10 minutes.

Study Arms (1)

Oclussion pressure

EXPERIMENTAL

The intervention consisted of measuring the esophageal pressure delta using an esophageal balloon (MBMed®). Once the balloon was placed and its correct position verified, NIV was initiated in three different scenarios (see procedure - NIV scenarios) in a randomized sequence, with allocation determined by sealed envelopes. During each scenario, ΔPocc was measured on the ventilator using an expiratory hold (3 measurements per scenario), and a stabilization period of 10 minutes was established before moving on to the next scenario.

Diagnostic Test: airway pressure occlusion measurement

Interventions

airway pressure occlusion measurement DIAGNOSTIC_TEST

Flow, airway pressure (Paw), and esophageal pressure (Pes) will be recorded for 10 minutes on different NIV settings: during each one, three end-expiratory airway occlusions will be applied at random intervals. Each occlusion was maintained for the duration of a single breath deflection in Paw from PEEP, confirmed by the return of Paw to baseline.

Oclussion pressure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects over 18 years old who wish to participate were included.

Sponsors & Collaborators

• Clinica Olivos SMG: lead
• Hospital Nacional Profesor Alejandro Posadas: collaborator

Study Sites (1)

Swiss Medical Group

Buenos Aires, 1636, Argentina

Location

Related Publications (15)

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Study Officials

• Marina Busico, RT

  Argentine Society of Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 12, 2022
• Study Start: October 30, 2022
• Primary Completion: January 1, 2023
• Study Completion: September 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

AR (1)