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

Respiration, Artificial Clinical Trial

— WEAN-US  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008875
• Other study ID #: DM-CS-003
• Status: Completed
• Start date: April 11, 2019
• Est. completion date: October 14, 2020

Study information

• Verified date: June 2021
• Source: Respinor AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 14, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration, Artificial

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CH Saint Joseph Saint Luc	Lyon
France	Hôpital Universitaire Pitié Salpêtrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Respinor AS	European Commission

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Llamas-Álvarez AM, Tenza-Lozano EM, Latour-Pérez 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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
Secondary	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