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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?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05539599
Enrollment
89
Registered
2022-09-14
Start date
2022-09-09
Completion date
2024-05-08
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Weaning, Weaning Failure

Keywords

weaning, MV critically ill patients, Ultrasound evaluation

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.

Interventions

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

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessing the prognostic value of a combined score in predicting weaning success72 hoursWe 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

MeasureTime frameDescription
Interaction between days of mechanical ventilator and determinant of weaning success28 daysWe 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026