Monitoring Intercostal Muscles After Extubation

NCT02853201 | Completed

• 1 other identifier: REB# 16-161
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation is a life-saving treatment for critically ill patients who are unable to breathe on their own. At the time of recovery, separation from the ventilator is performed without difficulty for the majority of patients. However, approximately 15% of patients experience extubation failure, i.e. they are re-intubated after extubation within a period of 48 hours to 7 days. Patients who fail extubation are exposed to a longer duration of mechanical ventilation, higher rates of ventilator-acquired pneumonia, higher morbidity, and higher ICU mortality. Therefore, it is of relevant importance for clinicians to identify patients who are at risk of extubation failure as soon as ventilation has been discontinued. However, current clinical assessment has poor predictive performance: some physiological variables can be helpful but can only be obtained invasively using esophageal and gastric catheters. Using ultrasound measurements to assess the activity of the respiratory muscles could be of particular interest for this purpose. By showing an early recruitment of the accessory muscles as well as diaphragm dysfunction or hyperactivity, ultrasounds could help clinicians pay greater attention to such patients and therefore try to apply specific therapeutics. There are several advantages to ultrasounds: they are non-invasive, available in most intensive care units, and previous studies have reported reasonable reliability of the measurements. In the present study, we aim to assess the contractility of the respiratory muscles (diaphragm, intercostal, and sternocleidomastoid) using ultrasounds to identify patients who may be at risk of extubation failure and/or ICU readmission.

Conditions

Respiratory Insufficiency

Keywords

Extubation; Intercostal Muscles; Diaphragm; Sternocleidomastoid Muscle

Outcome Measures

Primary Outcomes (1)

• Comparison of the thickening fraction of each muscle (diaphragm, intercostal, and sternocleidomastoid) between 2 groups of patients regarding the occurrence of extubation failure risk and ICU readmission.

  Up to 7 days after extubation

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Extubated ICU patients.

You may qualify if:

• Invasive mechanical ventilation ≥ 48 hours
• Successful spontaneous breathing trial completed and extubation decided by the attending physician

You may not qualify if:

• Withholding or withdrawal of life support
• Patients under extracorporeal membrane oxygenation circuit
• Impossibility to perform ultrasound of the diaphragm of the two accessory muscles: neck surgery, C-spine collar, Halo vest, morbid obesity. Patients will be enrolled as long as access to at least two locations is feasible (intercostal, diaphragm, or sternocleidomastoid).
• Known (hemi) diaphragm paralysis

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (17)

• Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.

  PMID: 23641924 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Goligher EC, Laghi F, Detsky ME, Farias P, Murray A, Brace D, Brochard LJ, Bolz SS, Rubenfeld GD, Kavanagh BP, Ferguson ND. Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity. Intensive Care Med. 2015 Apr;41(4):642-9. doi: 10.1007/s00134-015-3687-3. Epub 2015 Feb 19.

  PMID: 25693448 BACKGROUND

• Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186.

  PMID: 9228375 BACKGROUND

• Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93. doi: 10.1164/ajrccm.158.2.9711045.

  PMID: 9700126 BACKGROUND

• Parthasarathy S, Jubran A, Laghi F, Tobin MJ. Sternomastoid, rib cage, and expiratory muscle activity during weaning failure. J Appl Physiol (1985). 2007 Jul;103(1):140-7. doi: 10.1152/japplphysiol.00904.2006. Epub 2007 Mar 29.

  PMID: 17395760 BACKGROUND

• DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

  PMID: 24365607 BACKGROUND

• Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.

  PMID: 24949192 BACKGROUND

• 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.

  PMID: 21705883 BACKGROUND

• Jung B, Moury PH, Mahul M, de Jong A, Galia F, Prades A, Albaladejo P, Chanques G, Molinari N, Jaber S. Diaphragmatic dysfunction in patients with ICU-acquired weakness and its impact on extubation failure. Intensive Care Med. 2016 May;42(5):853-861. doi: 10.1007/s00134-015-4125-2. Epub 2015 Nov 16.

  PMID: 26572511 BACKGROUND

• Adler D, Dupuis-Lozeron E, Richard JC, Janssens JP, Brochard L. Does inspiratory muscle dysfunction predict readmission after intensive care unit discharge? Am J Respir Crit Care Med. 2014 Aug 1;190(3):347-50. doi: 10.1164/rccm.201404-0655LE. No abstract available.

  PMID: 25084264 BACKGROUND

• Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

  PMID: 26167730 BACKGROUND

• Cala SJ, Kenyon CM, Lee A, Watkin K, Macklem PT, Rochester DF. Respiratory ultrasonography of human parasternal intercostal muscle in vivo. Ultrasound Med Biol. 1998 Mar;24(3):313-26. doi: 10.1016/s0301-5629(97)00271-8.

  PMID: 9587987 BACKGROUND

• Jesus FM, Ferreira PH, Ferreira ML. Ultrasonographic measurement of neck muscle recruitment: a preliminary investigation. J Man Manip Ther. 2008;16(2):89-92. doi: 10.1179/106698108790818486.

  PMID: 19119393 BACKGROUND

• Frutos-Vivar F, Ferguson ND, Esteban A, Epstein SK, Arabi Y, Apezteguia C, Gonzalez M, Hill NS, Nava S, D'Empaire G, Anzueto A. Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest. 2006 Dec;130(6):1664-71. doi: 10.1378/chest.130.6.1664.

  PMID: 17166980 BACKGROUND

• Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.

  PMID: 21765357 BACKGROUND

• Thille AW, Cortes-Puch I, Esteban A. Weaning from the ventilator and extubation in ICU. Curr Opin Crit Care. 2013 Feb;19(1):57-64. doi: 10.1097/MCC.0b013e32835c5095.

  PMID: 23235542 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: August 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)