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

April 11, 2018 updated by: Unity Health Toronto

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

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Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time from catheter positioning to first EAdi signal
Time Frame: Up to 5 days
> 5uV lasting at least 5 minutes
Up to 5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time from endotracheal intubation to first EAdi signal
Time Frame: Up to 5 days
Up to 5 days
Time from catheter positioning until 24 hours of continuous EAdi signal
Time Frame: Up to 5 days
Up to 5 days
Number of patients without EAdi signal in the first 72 hours after intubation
Time Frame: Up to 3 days
Up to 3 days
Patient-ventilator interaction assessed by EAdi
Time Frame: Up to 5 days
Up to 5 days
Clinical characteristics associated with diaphragm inactivity
Time Frame: Up to 5 days
Up to 5 days
Correlation between diaphragm muscle thickness and diaphragm thickening fraction
Time Frame: Up to 5 days
Up to 5 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Correlation between the electrical activity of the diaphragm and diaphragm and intercostal thickening fraction
Time Frame: Up to 5 days
Up to 5 days
Correlation between thickening fraction of the intercostal muscles and of the diaphragm
Time Frame: Up to 5 days
Up to 5 days
Changes in diaphragm and intercostal muscle thickness over time
Time Frame: Up to 5 days
Up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent J. Brochard, MD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB #15-073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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