Improvement of Weaning From Mechanical Ventilation by Continuous

Status Completed

Clinical Trial Summary

Justification: The diaphragm is the main inspiratory muscle. Its dysfunction therefore compromises ventilation, which is necessary for gas exchange. Diaphragmatic dysfunction is frequently observed in resuscitation patients. Diaphragm ultrasound is currently a simple and validated technique for measuring the function of the diaphragm in intensive care. However, the discontinuity of the measurements is one of the major limitations of the current, standard ultrasonic evaluation of diaphragm function. Respinor AS (Oslo, Norway) has developed an ultrasound device (known as RESPINOR DXT) for continuous quantification of diaphragmatic excursion and velocity. Aims of the study: To evaluate the feasibility of the continuous monitoring of the diaphragmatic excursion using RESPINOR DXT in patients undergoing MV in the intensive care unit, to ensure its reliability and to establish a link between the diaphragmatic excursion and the weaning outcome of MV. Method: In addition to continuous diaphragm monitoring by RESPINOR DXT, a daily measurement of the diaphragm excursion will be performed using a conventional ultrasound system for comparison. A daily measurement of the oesophageal pressure (Pes) and the gastric pressure (Pga) will be performed, thus allowing the calculation of the transdiaphragmatic pressure (Pdi). Analysis: The feasibility of the measurement will be evaluated through user utility questions as well as the time spent with a signal meeting specific quality criteria. Its reliability will be studied by the concordance between the measurements of the excursion measured by RESPINOR DXT and by standard ultrasound (Bland-Altman, Passing-Bablock). It will be further evaluated by the correlation between the variations of the excursion measured by RESPINOR DXT and the Pdi variations. Receiver operating characteristic (ROC) curves will be performed to identify the optimal diaphragmatic excursion threshold for predicting weaning success and prognosis. Hypothesis: It is anticipated that the present study will show that the continuous monitoring of diaphragm excursion by RESPINOR DXT is reliable. Further, it is anticipated that there will be a statistical link between the diaphragmatic excursion and velocity of the movement measured by RESPINOR DXT before, during and after the spontaneous breathing trial.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Respiration, Artificial

Clinical Trial Details

NCT number	NCT04008875
Study type	Observational
Source	Respinor AS
Contact
Status	Completed
Phase
Start date	April 11, 2019
Completion date	October 14, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion — WEAN-US

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms