Comprehensive Ultrasound Evaluation as a Predictor of Weaning

Can Heart-lung-respiratory Muscles Ultrasound Evaluation Play a Role to Predict Weaning in Critically Ill Patients?

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.

Study Overview

• Status: Completed
• Conditions: Weaning Failure; Mechanical Ventilation Weaning
• Intervention / Treatment: Diagnostic test: Comprehensive evaluation

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 Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Università di Ferrara
  • Siena, Italy, 53100
    • Università di Siena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

mechanically ventilated patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; Patients will undergo a spontaneous breathing trial. Any extubation will be decided by an independent operator.	Diagnostic test: Comprehensive evaluation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interaction between days of mechanical ventilator and determinant of weaning success	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	28 days

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: weaning; Ultrasound evaluation; MV critically ill patients
• Other Study ID Numbers: WEAN_US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No