Comprehensive Ultrasound Evaluation as a Predictor of Weaning

Completed

• Conditions: Mechanical Ventilation Weaning; Weaning Failure
• Interventions: Diagnostic Test: Comprehensive evaluation

• Registration Number: NCT05539599
• Lead Sponsor: Università degli Studi di Ferrara

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.

Detailed Description

Critically ill patients undergone at least 48 hours of MV and ready to spontaneous breathing trial (SBT) will be included in the study. The spontaneous breathing trial is performed in pressure support ventilation with a clinician-set positive end expiratory pressure (PEEP) ≤ 5 cm H2O and FiO2\< 40%. In addition to the parameters traditionally used for the evaluation of weaning (RSBI), the investigators will perform ultrasound evaluation of diaphragm, lung parenchyma, cardiac function, and the strength of the hand grip.

Investigators will evaluate the diaphragmatic parameters (thickening fraction,TF, and diaphragmatic displacement, DD) and TFmax (TF during forced breathing /TF during tidal respiration) to identify the inspiratory reserve. Weaning success is considered as liberation from MV within 72 hours.

Study Timeline

• Study First Submitted: 2022-09-08
• Study Start: 2022-09-09
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-14
• Status Verified: 2024-05
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-08
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Comprehensive evaluation	Patients will undergo a spontaneous breathing trial. Any extubation will be decided by an independent operator.

Primary Outcome Measures

Name	Time	Method
Assessing the prognostic value of a combined score in predicting weaning success	72 hours	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.

Secondary Outcome Measures

Name	Time	Method
Interaction between days of mechanical ventilator and determinant of weaning success	28 days	We will assess the interaction between days of mechanical ventilation and the prognostic value of Central venous pressure, hand-grip strength evaluation, P0.1, Maximal inspiratory pressure, Blood gas analysis, Diaphragmatic displacement, thickening fraction, TFmax, E/e', Triscuspidal annular Plane Systolic Excursion, Lung score in predicting weaning success

Trial Locations

Locations (2)

Università di Siena; 🇮🇹 Siena, Italy

Università di Ferrara; 🇮🇹 Ferrara, Italy