Respiratory InsufficiencyDIVIPNCT02434016
Assessing Diaphragm Muscle Inactivity in Mechanically Ventilated ICU Patients
An observational study of Respiratory Insufficiency, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Insufficiency
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Phrenic nerve lesions (past medical history)
- Contraindications to the insertion of a naso- or oro-gastric (feeding) tube
- Patients already intubated for > 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from catheter positioning to first EAdi signal
> 5uV lasting at least 5 minutes
Measured: Up to 5 days
Secondary outcomes (6)
Time from endotracheal intubation to first EAdi signal
Measured: Up to 5 days
Time from catheter positioning until 24 hours of continuous EAdi signal
Measured: Up to 5 days
Number of patients without EAdi signal in the first 72 hours after intubation
Measured: Up to 3 days
Patient-ventilator interaction assessed by EAdi
Measured: Up to 5 days
Clinical characteristics associated with diaphragm inactivity
Measured: Up to 5 days
Correlation between diaphragm muscle thickness and diaphragm thickening fraction
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent J. Brochard, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434016
- Sponsor's protocol ID
- REB #15-073
- Acronym
- DIVIP
- Status last verified
- Apr 2018
- First submitted
- 27 Apr 2015
- Last updated
- 12 Apr 2018
- Results posted
- No
Publications
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.
PubMed 17855814Levine 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.
PubMed 18367735Jaber 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.
PubMed 20813887Sassoon 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.
PubMed 15201132Doorduin 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.
PubMed 23103733Heunks 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.
PubMed 25546533Sinderby 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.
PubMed 10581089Sklar 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.
PubMed 33430930
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Diaphragm Muscle Inactivity in Mechanically Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT02434016
- Acronym / sponsor ID
- DIVIP / REB #15-073
- Conditions
- Respiratory Insufficiency
- Keywords
- Diaphragm, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- Phrenic nerve lesions (past medical history)
- Contraindications to the insertion of a naso- or oro-gastric (feeding) tube
- Patients already intubated for > 12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time from catheter positioning to first EAdi signal
Time frame: Up to 5 days
> 5uV lasting at least 5 minutes
6 secondary outcomes
Time from endotracheal intubation to first EAdi signal
Time frame: Up to 5 days
Time from catheter positioning until 24 hours of continuous EAdi signal
Time frame: Up to 5 days
Number of patients without EAdi signal in the first 72 hours after intubation
Time frame: Up to 3 days
Patient-ventilator interaction assessed by EAdi
Time frame: Up to 5 days
Clinical characteristics associated with diaphragm inactivity
Time frame: Up to 5 days
Correlation between diaphragm muscle thickness and diaphragm thickening fraction
Time frame: Up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Background: PubMed 17855814De 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.
- Background: PubMed 18367735Levine 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.
- Background: PubMed 20813887Jaber 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.
- Background: PubMed 15201132Sassoon 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.
- Background: PubMed 23103733Doorduin 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.
- Background: PubMed 25546533Heunks 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.
- Background: PubMed 10581089Sinderby 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.
- Derived from this study: PubMed 33430930Sklar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent J. Brochard, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from catheter positioning to first EAdi signal (time frame: Up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434016, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.