Clinical trial NCT05539599: Comprehensive Ultrasound Evaluation as a Predictor of Weaning
Official title: Can Heart-lung-respiratory Muscles Ultrasound Evaluation Play a Role to Predict Weaning in Critically Ill Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Weaning
Weaning Failure
Keywords: weaning
MV critically ill patients
Ultrasound evaluation
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mechanically ventilated patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing the prognostic value of a combined score in predicting weaning success
timeFrame: 72 hours
Secondary outcomes:
measure: Interaction between days of mechanical ventilator and determinant of weaning success
timeFrame: 28 days
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Università di Ferrara
city: Siena
country: Italy
facility: Università di Siena
Study officials:
References: