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Assessing Diaphragm Muscle Inactivity in Mechanically Ventilated ICU Patients (DIVIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434016
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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)


Condition or disease
Respiratory Insufficiency

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time from catheter positioning to first EAdi signal [ Time Frame: Up to 5 days ]
    > 5uV lasting at least 5 minutes


Secondary Outcome Measures :
  1. Time from endotracheal intubation to first EAdi signal [ Time Frame: Up to 5 days ]
  2. Time from catheter positioning until 24 hours of continuous EAdi signal [ Time Frame: Up to 5 days ]
  3. Number of patients without EAdi signal in the first 72 hours after intubation [ Time Frame: Up to 3 days ]
  4. Patient-ventilator interaction assessed by EAdi [ Time Frame: Up to 5 days ]
  5. Clinical characteristics associated with diaphragm inactivity [ Time Frame: Up to 5 days ]
  6. Correlation between diaphragm muscle thickness and diaphragm thickening fraction [ Time Frame: Up to 5 days ]

Other Outcome Measures:
  1. Correlation between the electrical activity of the diaphragm and diaphragm and intercostal thickening fraction [ Time Frame: Up to 5 days ]
  2. Correlation between thickening fraction of the intercostal muscles and of the diaphragm [ Time Frame: Up to 5 days ]
  3. Changes in diaphragm and intercostal muscle thickness over time [ Time Frame: Up to 5 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434016


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Laurent J. Brochard, MD St. Michael's Hospital, Toronto
Publications:

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02434016    
Other Study ID Numbers: REB #15-073
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Keywords provided by St. Michael's Hospital, Toronto:
Diaphragm
Mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases