Assessing Diaphragm Muscle Inactivity in Mechanically Ventilated ICU Patients

Respiratory Insufficiency Clinical Trial

— DIVIP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434016
• Other study ID #: REB #15-073
• Status: Completed
• First received: April 27, 2015
• Last updated: April 11, 2018
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Non-inclusion Criteria:

• 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

Exclusion Criteria:

• Phrenic nerve lesions (past medical history)

• Contraindications to the insertion of a naso- or oro-gastric (feeding) tube

• Patients already intubated for > 12 hours

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (7)

De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Réflexion et d'Etude des Neuromyopathies en Réanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. — View Citation

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. — View Citation

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. — 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

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

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. Epub 2004 Jun 16. — View Citation

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between the electrical activity of the diaphragm and diaphragm and intercostal thickening fraction		Up to 5 days
Other	Correlation between thickening fraction of the intercostal muscles and of the diaphragm		Up to 5 days
Other	Changes in diaphragm and intercostal muscle thickness over time		Up to 5 days
Primary	Time from catheter positioning to first EAdi signal	> 5uV lasting at least 5 minutes	Up to 5 days
Secondary	Time from endotracheal intubation to first EAdi signal		Up to 5 days
Secondary	Time from catheter positioning until 24 hours of continuous EAdi signal		Up to 5 days
Secondary	Number of patients without EAdi signal in the first 72 hours after intubation		Up to 3 days
Secondary	Patient-ventilator interaction assessed by EAdi		Up to 5 days
Secondary	Clinical characteristics associated with diaphragm inactivity		Up to 5 days
Secondary	Correlation between diaphragm muscle thickness and diaphragm thickening fraction		Up to 5 days