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

February 6, 2024 updated by: Candelaria de Haro, Corporacion Parc Tauli
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Candelaria De Haro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pimax and diaphragm inspiratory excursion
Time Frame: 4 months
To assess the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicting value of diaphragm excursion
Time Frame: 4 months
To assess the predicting value of the diaphragm maximum inspiratory excursion measured with ultrasound for the weaning success.
4 months
Combination index prediction for weaning
Time Frame: 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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECO-MIP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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