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

NCT03091413 | Withdrawn

• 1 other identifier: ECO-MIP
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weaning; Diaphragm Ultrasound; Maximum Inspiratory Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Predicting value of diaphragm excursion

  4 months

• Combination index prediction for weaning

  4 months

Study Arms (1)

case group

diaphragm ultrasounds during weaning and Pimax measures

Diagnostic Test: diaphragm ultrasound

Interventions

diaphragm ultrasound DIAGNOSTIC_TEST

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.

case group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All ICU patients of Hospital de Sabadell who meet criteria for weaning will be included in the study.

You may qualify if:

• Age \> 18 years.
• Invasive Mechanical Ventilation \> 24 hours.
• Readiness for weaning (following clinician decision made according to recent guidelines).

You may not qualify if:

• Impossibility to perform an echography.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Candelaria De Haro

Sabadell, Barcelona, 08208, Spain

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: April 4, 2022
• Primary Completion: April 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

ES (1)