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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

Tracking Information
First Submitted Date March 21, 2017
First Posted Date March 27, 2017
Last Update Posted Date February 1, 2019
Actual Study Start Date March 17, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2017)
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.
Original Primary Outcome Measures
 (submitted: March 21, 2017)
To assess the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound. [ Time Frame: 4 months ]
Change History Complete list of historical versions of study NCT03091413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 28, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: March 21, 2017)
  • To assess the predicting value of the diaphragm maximum inspiratory excursion measured with ultrasound for the weaning success. [ 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. [ Time Frame: 4 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning
Official Title Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All ICU patients of Hospital de Sabadell who meet criteria for weaning will be included in the study.
Condition
  • Weaning
  • Diaphragm Ultrasound
  • Maximum Inspiratory Pressure
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.

Study Groups/Cohorts case group
diaphragm ultrasounds during weaning and Pimax measures
Intervention: Diagnostic Test: diaphragm ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 21, 2017)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03091413
Other Study ID Numbers ECO-MIP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Candelaria de Haro, Corporacion Parc Tauli
Study Sponsor Corporacion Parc Tauli
Collaborators Not Provided
Investigators Not Provided
PRS Account Corporacion Parc Tauli
Verification Date January 2019