Non-invasive Respiratory Monitoring During SBT

NCT05295186 | Completed DMC

• 1 other identifier: SBT_PAV01
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 2

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

Conditions

Mechanical Ventilation Complication; Acute Respiratory Failure; Re-intubation Rate

Keywords

spontaneous breathing trial; Extubation failure; lung mechanics; airway occlusion pressure; noninvasive monitoring

Outcome Measures

Primary Outcomes (1)

• Advance Respiratory mechanics assessment during SBT

  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

  30 minutes

Secondary Outcomes (1)

• discriminatory power

  72 hours

Study Arms (1)

Patients at high-risk for re-intubation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High-risk patients for re-intubation were defined as follow : The presence of ≥ 1 among the following factors to define the high-risk for re-intubation: age older than 65 years; heart failure as the primary indication for mechanical ventilation; moderate to severe chronic obstructive pulmonary disease (COPD); an Acute Physiology and Chronic Health Evaluation II (APACHE II) score higher than 12 on extubation day; body mass index of more than 30; inadequate cough reflex or suctioning \>2 times within 8 hours before extubation; prolonged use of invasive ventilation (≥ 7 days from the first SBT); more than 2 comorbidities categorized based on the Charlson Comorbidity Index.

Sponsors & Collaborators

• University of Bari: lead
• Università degli Studi di Ferrara: collaborator
• Catholic University of the Sacred Heart: collaborator
• Università degli Studi di Sassari: collaborator
• University of Turin, Italy: collaborator

Study Sites (2)

Azienda Ospedaliero Universitaria Policlinico

Bari, 70124, Italy

Location

Salvatore Grasso

Bari, 70124, Italy

Location

Related Publications (1)

• Murgolo F, Spadaro S, Grieco DL, Bertoni M, Pisani L, Spinazzola G, Di Mussi R, Michi T, Bartolomeo N, Fanelli V, Terragni P, Antonelli M, Ranieri VM, Grasso S. Assessment of Respiratory Mechanics and Inspiratory Effort During Spontaneous Breathing Trials to Predict Extubation Failure in High-Risk Patients. Am J Respir Crit Care Med. 2025 Dec;211(12):2340-2351. doi: 10.1164/rccm.202503-0544OC.

  PMID: 41072398 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROF

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 25, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 5, 2025

Record last verified: 2024-04

Locations

IT (2)