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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091413
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Candelaria de Haro, Corporacion Parc Tauli

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
Weaning Diaphragm Ultrasound Maximum Inspiratory Pressure Diagnostic Test: diaphragm ultrasound

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Study Type : Observational
Estimated 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 : March 17, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091413


Locations
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Spain
candelaria De Haro
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli

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Responsible Party: Candelaria de Haro, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03091413    
Other Study ID Numbers: ECO-MIP
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes