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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiration, Artificial

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers
  • Lyon, France
    • CH Saint Joseph Saint Luc
  • Paris, France
    • Hôpital Universitaire Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients on mechanical ventilation in the intensive care unit for greater than 24 hours

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Successful weaning/extubation; Successful weaning will be defined as a patient who completes a planned 30-minute spontaneous breathing trial. Successful extubation will be defined as a patient who completes a planned 30-minute spontaneous breathing trial and is not reintubated in the first 48 hours after extubation.
Failed weaning/extubation; Failed weaning will be defined as a patient who did not complete a planned 30-minute spontaneous breathing trial. Failed extubation will be defined as a patient who did not complete a planned 30-minute spontaneous breathing trial, in the first 48 hours after extubation are reintubated, have unplanned non-invasive ventilation (NIV) or who have a tracheostomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User-completed 5-point utility questions	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.	Day 1 of enrolment
Incidence of pressure sores.	The investigators will measure the incidence of pressure sores at the site of the investigative device sensors in patients throughout the period of enrolment.	Up to 14 days (the period of enrolment of the patient)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between diaphragm excursion measurements.	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.	Up to 14 days (the period of enrolment of the patient)
Changes in diaphragm excursion during the SBT.	Receiver operating characteristic (ROC) curves will be performed to identify the optimal diaphragmatic excursion threshold for predicting weaning success.	From 30 minutes before the SBT up to 30 minutes post-SBT
Correlation between the diaphragm velocity and transdiaphragmatic pressure measurements.	Correlations between diaphragm velocity measured by the RESPINOR DXT and the Pdi variations measured by the orogastric catheter will be made.	From 30 minutes before the SBT up to 30 minutes post-SBT

Collaborators and Investigators

• Sponsor: Respinor AS
• Collaborators: European Commission

Publications and helpful links

General Publications

• Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. doi: 10.1378/chest.126.1.179.
• Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
• Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
• Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
• Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
• Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.
• Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.
• Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2019
• Primary Completion (ACTUAL): July 8, 2020
• Study Completion (ACTUAL): October 14, 2020

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: mechanical ventilation; diaphragm function; diaphragm ultrasound
• Other Study ID Numbers: DM-CS-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No