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NCT03091413 Clinical Trial

Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning

Weaning Clinical Trial

Official title:
Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03091413
Other study ID # ECO-MIP
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date April 4, 2022
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from invasive mechanical ventilation.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years. - Invasive Mechanical Ventilation > 24 hours. - Readiness for weaning (following clinician decision made according to recent guidelines). Exclusion Criteria: - Impossibility to perform an echography.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• diaphragm ultrasound
For each patient intubated and ventilated in our ICU we will performed diaphragm ultrasound during the weaning process. We will performed the measurement of diaphragmatic maximum excursion during a maximal inspiration using an abdominal standard preset with M-mode, with the so called anatomical M-mode. We will put the probe in the right subcostal window to use the hepatic window to assess the movement of the diaphragm. We will performed the measure of the diaphragm excursion with patient in semi-recumbent position and through a transhepatic transverse oblique scan while the patient is on mechanical ventilation and undergo a Pimax maneuver, that consists in a temporary occlusion of the airway with an expiratory pause. We will performed the measure three times, and we will take into account the best one made by the patient.

Locations
Country Name City State
Spain Candelaria De Haro Sabadell Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pimax and diaphragm inspiratory excursion To assess the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound. 4 months
Secondary Predicting value of diaphragm excursion To assess the predicting value of the diaphragm maximum inspiratory excursion measured with ultrasound for the weaning success. 4 months
Secondary Combination index prediction for weaning To assess if the diaphragm maximum inspiratory excursion measured with ultrasound alone or in combination with other index (RSBI, ?tdi%) can predict the weaning success. 4 months
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