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Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA

Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05990348
Acronym
InterThick
Enrollment
20
Registered
2023-08-14
Start date
2022-07-01
Completion date
2025-09-30
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure, Weaning Failure

Brief summary

the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) . Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive. However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.

Detailed description

Respiratory muscles dysfunction is one of the main causes leading to failure of weaning from mechanical ventilation (MV) in critically ill patients. Muscular activity is important during the inspiratory phase of ventilation, which is mainly due to diaphragm and external intercostal muscles. Diaphragm dysfunction is frequent among critically ill patients and ranges from 33 to 95% . Although several indexes have been investigated to help clinician in identifying its disturbance, their clinical value is controversial . External intercostal muscles dysfunction epidemiology is unknown because of lack of non-invasive tool to investigate such condition. However, the echography assessment of intercostal muscles thickening fraction (TFic) has shown promising results in this field as a non-invasive tool to assess inspiratory muscle function and predict weaning failure . On the other hand, the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) \[. Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive . A recent study suggests that EAdi and derived parameters, may be helpful to predict weaning failure in chronic obstructive pulmonary disease (COPD) patients . However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU. the aim of this study will be the comparison of TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU and the assessment of the inspiratory effort parameters and the occurrence of respiratory asynchrony in patients with difficult weaning from MV admitted in ICU.

Interventions

OTHERdifficult weaning patients

intercostal thickening fraction values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients who have failed at least one weaning attempt * mechanical ventilation for at least 24 hours

Exclusion criteria

* Pregnancy * Obesity (Body Mass Index \> 35 kg/m2) * Contraindication to the insert of a nasogastric tube * Neuromuscular diseases

Design outcomes

Primary

MeasureTime frameDescription
intercostal thickening fractionFrom date of enrollment until the date of extubation (up to seven days)intercostal thickening fraction values during PSV and NAVA

Countries

Italy

Contacts

Primary Contactgiorgia GS spinazzola, md
giorgia.spinazzola@policlinicogemelli.it0630154507
Backup Contactgianmarco gm maresca, md
gianmarco.maresca@policlinicogemelli.it0630154507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026