Comprehensive Ultrasound Evaluation as a Predictor of Weaning

Weaning Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05539599
• Other study ID #: WEAN_US
• Status: Completed
• Start date: September 9, 2022
• Est. completion date: May 8, 2024

Study information

• Verified date: May 2024
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 8, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Weaning
• Weaning Failure

Intervention

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

Locations

Country	Name	City	State
Italy	Università di Ferrara	Ferrara
Italy	Università di Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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