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

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Recruiting

CT.gov ID

NCT03091413

Collaborator

(none)

Enrollment

Location

32.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weaning Diaphragm Ultrasound Maximum Inspiratory Pressure	Diagnostic Test: diaphragm ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 4, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
case group diaphragm ultrasounds during weaning and Pimax measures	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.

Arm

Intervention/Treatment

case group

diaphragm ultrasounds during weaning and Pimax measures

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.

Outcome Measures

Primary Outcome Measures

Pimax and diaphragm inspiratory excursion [4 months]
To assess the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound.

Secondary Outcome Measures

Predicting value of diaphragm excursion [4 months]
To assess the predicting value of the diaphragm maximum inspiratory excursion measured with ultrasound for the weaning success.
Combination index prediction for weaning [4 months]
To assess if the diaphragm maximum inspiratory excursion measured with ultrasound alone or in combination with other index (RSBI, Δtdi%) can predict the weaning success.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Candelaria De Haro	Sabadell	Barcelona	Spain	08208

Sponsors and Collaborators

Corporacion Parc Tauli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Candelaria de Haro, MD, Corporacion Parc Tauli

ClinicalTrials.gov Identifier:

NCT03091413

Other Study ID Numbers:

ECO-MIP

First Posted:

Mar 27, 2017

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Aspiration

Study Results

No Results Posted as of Apr 27, 2022