Assessing Diaphragm Muscle Inactivity in Mechanically Ventilated ICU Patients

NCT02434016 | Completed

• 1 other identifier: REB #15-073
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Mechanical ventilation is a life saving intervention in patients with acute respiratory failure, for instance, due to infection or trauma. The main goals of mechanical ventilation are to improve oxygenation and decrease the load imposed on the respiratory muscles. Unfortunately, mechanical ventilation comes with adverse events including disuse atrophy and weakness of the respiratory muscles. The diaphragm is the main muscle for inspiration and therefore this clinical entity is commonly referred to as ventilator-induced diaphragm dysfunction (VIDD). Several studies have shown that inspiratory muscle weakness is associated with adverse outcomes, including prolonged duration of mechanical ventilation. Inactivity or disuse is a recognized risk factor for the development of VIDD: disuse may result from excessive unloading of the diaphragm by the ventilator. Therefore, clinicians aim to limit the risk of VIDD by using ventilator modes that allow patients to perform at least part of the total work of breathing when deemed clinically appropriate. However, even when these so-called assisted modes for ventilation are used, excessive unloading of the diaphragm may occur; without using technology that allows monitoring of diaphragm function, the clinician is often uncertain as to whether this muscle is indeed actively working. Continuous recording of the electrical activity of the diaphragm (EAdi) is used to monitor diaphragm muscle activity in ICU patients. Furthermore, sonographic measurements of diaphragm thickness allows for an easy quantification of diaphragmatic activity (thickening fraction) as well as providing a potentially useful mechanism for studying diaphragm injury and function during mechanical ventilation. Aim: To assess the duration of diaphragm muscle inactivity in patients admitted to the ICU using EAdi monitoring and to assess the correlation between diaphragm thicknening fraction, as measured by ultrasound, and electrical activity, as measured by EAdi. Hypothesis: Diaphragm muscle inactivity frequently occurs in the early phase of ICU admission Design: Observational pilot study in ventilated adult ICU patients admitted to the ICU at St Michael's Hospital. The investigators aim to enroll 75 patients. Primary outcome: Time from catheter positioning to first EAdi (\> 5 uV last at least 5 minutes)

Conditions

Respiratory Insufficiency

Keywords

Diaphragm; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Time from catheter positioning to first EAdi signal

  \> 5uV lasting at least 5 minutes

  Up to 5 days

Secondary Outcomes (6)

• Time from endotracheal intubation to first EAdi signal

  Up to 5 days

• Time from catheter positioning until 24 hours of continuous EAdi signal

  Up to 5 days

• Number of patients without EAdi signal in the first 72 hours after intubation

  Up to 3 days

• Patient-ventilator interaction assessed by EAdi

  Up to 5 days

• Clinical characteristics associated with diaphragm inactivity

  Up to 5 days

Other Outcomes (3)

• Correlation between the electrical activity of the diaphragm and diaphragm and intercostal thickening fraction

  Up to 5 days

• Correlation between thickening fraction of the intercostal muscles and of the diaphragm

  Up to 5 days

• Changes in diaphragm and intercostal muscle thickness over time

  Up to 5 days

Eligibility Criteria

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

Study Population

Patients admitted to the ICU in whom the attending clinician has decided to insert the dedicated feeding tube (EAdi catheter) in the ICU or \< 12 hours before admission

You may qualify if:

• Patient admitted to the ICU
• Intubation in the ICU or \< 12 hours before admission
• Expected duration of mechanical ventilation \> 48 h
• Edi monitoring tube / catheter in situ by the clinical team
• Anticipated removal of EAdi tube within 48 hours of ICU admission (e.g., for MRI, for endoscopic intervention)
• High risk for intracranial hypertension or proven intracranial hypertension due to severe neurotrauma or substantial intracranial hemorrhage because these patients will likely need Magnetic Resonance Imaging. This can be discussed on a case-by-case basis based on the severity and initial findings
• Lack of Servo-i NAVA capable ventilator, lack of EAdi catheter

You may not qualify if:

• Phrenic nerve lesions (past medical history)
• Contraindications to the insertion of a naso- or oro-gastric (feeding) tube
• Patients already intubated for \> 12 hours

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (8)

• De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.

  PMID: 17855814 BACKGROUND

• 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.

  PMID: 18367735 BACKGROUND

• 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.

  PMID: 20813887 BACKGROUND

• Sassoon CS, Zhu E, Caiozzo VJ. Assist-control mechanical ventilation attenuates ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Sep 15;170(6):626-32. doi: 10.1164/rccm.200401-042OC. Epub 2004 Jun 16.

  PMID: 15201132 BACKGROUND

• Doorduin J, van Hees HW, van der Hoeven JG, Heunks LM. Monitoring of the respiratory muscles in the critically ill. Am J Respir Crit Care Med. 2013 Jan 1;187(1):20-7. doi: 10.1164/rccm.201206-1117CP. Epub 2012 Oct 26.

  PMID: 23103733 BACKGROUND

• Heunks LM, Doorduin J, van der Hoeven JG. Monitoring and preventing diaphragm injury. Curr Opin Crit Care. 2015 Feb;21(1):34-41. doi: 10.1097/MCC.0000000000000168.

  PMID: 25546533 BACKGROUND

• Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.

  PMID: 10581089 BACKGROUND

• Sklar MC, Madotto F, Jonkman A, Rauseo M, Soliman I, Damiani LF, Telias I, Dubo S, Chen L, Rittayamai N, Chen GQ, Goligher EC, Dres M, Coudroy R, Pham T, Artigas RM, Friedrich JO, Sinderby C, Heunks L, Brochard L. Duration of diaphragmatic inactivity after endotracheal intubation of critically ill patients. Crit Care. 2021 Jan 11;25(1):26. doi: 10.1186/s13054-020-03435-y.

  PMID: 33430930 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Laurent J. Brochard, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 5, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

CA (1)