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Completed

NCT Number: NCT04008875

Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion

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.

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Key information

Conditions

Respiration, Artificial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years old
  • Consent to participate in the study
  • Affiliation to a social security scheme or entitled to it
  • Invasive mechanical ventilation for ≥ 24 hours
  • Richmond Agitation Sedation Scale (RASS) ≥ - 3 (Moderate sedation)
  • Able to tolerate spontaneous ventilation with inspiratory support ≤ 28 cmH2O
  • Absence of high-dose vasopressors defined by noradrenaline dosage < 0.3 μg / kg / min

Exclusion criteria

  • Central or spinal neurological lesion involving central ventilatory control or its transmission
  • Contraindication to the insertion of the oesophageal catheter, ie any contraindication to insertion or change of gastric tube, esophageal surgery of less than 14 days, oesophageal varices rupture of less than 4 days
  • Known neuromuscular disease, curare less than 24 hours (excluding succinylcholine for rapid sequence intubation), known hemidiaphragm paralysis or suspicion of hemidiaphragm paralysis (defined by elevation) dome> 2.5 cm compared to contralateral dome
  • Patient in therapeutic limitation
  • Pregnant woman, minor patient or protected adult

Treatment and study plan

Primary outcomes

  1. User-completed 5-point utility questions

    Time frame: Day 1 of enrolment

    Five-point scale to assess ease of application of the device. Scale used has options of very difficult, difficult, neutral, easy, very easy, with very easy being the better outcome and very difficult the worst.

  2. Incidence of pressure sores.

    Time frame: Up to 14 days (the period of enrolment of the patient)

    The investigators will measure the incidence of pressure sores at the site of the investigative device sensors in patients throughout the period of enrolment.

Secondary outcomes

  1. Concordance between diaphragm excursion measurements.

    Time frame: Up to 14 days (the period of enrolment of the patient)

    Comparison with a "gold standard". Concordance between diaphragm excursion measurements measured by the RESPINOR DXT monitor and standard ultrasound will be assessed using Bland-Altman analysis.

  2. Changes in diaphragm excursion during the SBT.

    Time frame: From 30 minutes before the SBT up to 30 minutes post-SBT

    Receiver operating characteristic (ROC) curves will be performed to identify the optimal diaphragmatic excursion threshold for predicting weaning success.

  3. Correlation between the diaphragm velocity and transdiaphragmatic pressure measurements.

    Time frame: From 30 minutes before the SBT up to 30 minutes post-SBT

    Correlations between diaphragm velocity measured by the RESPINOR DXT and the Pdi variations measured by the orogastric catheter will be made.

Sponsors and collaborators

Lead sponsor

Respinor AS

Industry

Collaborators

  • European Commission

Registry information

Official study title

Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion: the WEAN-US Study

Acronym: WEAN-US

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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