Non-invasive Respiratory Monitoring During SBT

Completed

• Conditions: Mechanical Ventilation Complication; Acute Respiratory Failure; Re-intubation Rate

• Registration Number: NCT05295186
• Lead Sponsor: University of Bari

Brief Summary

Spontaneous breathing trials (SBTs) assess readiness for extubation, yet the use of conventional parameters used to establish weaning success may be elusive, especially in high-risk patients. Currently, non-invasive techniques allow comprehensive bedside assessment of advanced respiratory mechanics, including metrics of respiratory system compliance (CRS), respiratory muscle effort (POCC) and respiratory drive intensity (P0.1). This study investigates whether these measurements during SBT may improve the prediction of extubation outcomes

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-25
• Study Start: 2022-09-01
• Status Verified: 2024-04
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Advance Respiratory mechanics assessment during SBT	30 minutes	The primary endpoint was to establish whether changes in CRS, POCC and P0.1 and/or their absolute values at the end of the PAV+ SBT differed between patients who subsequently required reintubation vs. those who were successfully extubated

Secondary Outcome Measures

Name	Time	Method
discriminatory power	72 hours	we aimed to test the discriminatory power of the absolute values of CRS, POCC and P0.1 at the end of SBT and discriminatory power of the SBT-induced percentage changes in these measurements during the trial in identifying patients who failed extubation.The decision to reintubate was made by the attending physicians, who were unaware of the study measurements results.

Trial Locations

Locations (2)

Azienda Ospedaliero Universitaria Policlinico; 🇮🇹 Bari, Italy

Salvatore Grasso; 🇮🇹 Bari, Italy