Comprehensive Ultrasound Evaluation as a Predictor of Weaning

NCT05539599 | Completed

• 1 other identifier: WEAN_US
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 2

Brief Summary

Several studies investigated the role of specific clinical predictors of weaning success, but it is determined by a combination of different aspects that can result in success or failure. Indeed, unresolved lung disease, cardiac dysfunction, loss of respiratory and core muscle strength can play a role in a failure weaning to mechanical ventilation (MV). The investigators hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success. Furthermore, it will be described weather the days of MV before weaning trial may affect the relevance of each clinical variable evaluated.

Conditions

Mechanical Ventilation Weaning; Weaning Failure

Keywords

weaning; MV critically ill patients; Ultrasound evaluation

Outcome Measures

Primary Outcomes (1)

• Assessing the prognostic value of a combined score in predicting weaning success

  We hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success.

  72 hours

Secondary Outcomes (1)

• Interaction between days of mechanical ventilator and determinant of weaning success

  28 days

Study Arms (1)

Cohort

Patients will undergo a spontaneous breathing trial. Any extubation will be decided by an independent operator.

Diagnostic Test: Comprehensive evaluation

Interventions

Comprehensive evaluation DIAGNOSTIC_TEST

Non-ultrasound parameters: Central venous pressure, hand-grip strength evaluation, P0.1, Maximal inspiratory pressure, Blood gas analysis ultrasound parameters: Diaphragmatic displacement, thickening fraction, TFmax, E/e', Triscuspidal annular Plane Systolic Excursion, Lung score

Cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

mechanically ventilated patients

You may qualify if:

• aged between 18 and 90 years
• Mechanical ventilation\> 48 h
• Reason for ICU admission: medical / surgical / trauma

You may not qualify if:

• age under 18
• diagnosis of neuromuscular disease
• tracheostomy
• terminal extubation
• pregnancy in progress -
• previous paralysis of the diaphragm or of a hemidiaphragm
• use of neuromuscular blocking drugs in continuous infusion in the 48 hours preceding the weaning attempt.
• Refusal to participate in the study

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (2)

Università di Ferrara

Ferrara, 44121, Italy

Location

Università di Siena

Siena, 53100, Italy

Location

Study Design

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

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 14, 2022
• Study Start: September 9, 2022
• Primary Completion: May 2, 2024
• Study Completion: May 8, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IT (2)