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Recruiting NCT05990348

NCT05990348 Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA

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Clinical Trial Summary
NCT ID NCT05990348
Status Recruiting
Phase
Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Condition Respiratory Failure
Study Type OBSERVATIONAL
Enrollment 20 participants
Start Date 2022-07-01
Primary Completion 2025-05-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
difficult weaning patients

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 20 participants in total. It began in 2022-07-01 with a primary completion date of 2025-05-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

giorgia GS spinazzola, md

✉ giorgia.spinazzola@policlinicogemelli.it

📞 0630154507

Frequently Asked Questions

Who can join the NCT05990348 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05990348 currently recruiting?

Yes, NCT05990348 is actively recruiting participants. Contact the research team at giorgia.spinazzola@policlinicogemelli.it for enrollment information.

Where is the NCT05990348 trial being conducted?

This trial is being conducted at Rome, Italy.

Who is sponsoring the NCT05990348 clinical trial?

NCT05990348 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 20 participants.

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