Comprehensive Ultrasound Evaluation as a Predictor of Weaning

NCT ID: NCT05539599

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2024-05-08

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.

Conditions

Mechanical Ventilation Weaning; Weaning Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

Patients will undergo a spontaneous breathing trial. Any extubation will be decided by an independent operator.

Comprehensive evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Alberto Fogagnolo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università di Ferrara

Ferrara, , Italy

Università di Siena

Siena, , Italy

Countries

Italy

Other Identifiers

WEAN_US

Identifier Type: -

Identifier Source: org_study_id