NCT03108118

Brief Summary

This study is designed to evaluate the relationship between diaphragm activity during mechanical ventilation and the development of ventilator-induced diaphragm dysfunction (VIDD). Diaphragm structure, activity, and function are monitored longitudinally over the first 7 days of mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

6.4 years

First QC Date

April 4, 2017

Last Update Submit

January 15, 2020

Conditions

Respiratory InsufficiencyDiaphragm InjuryMechanical Ventilation Complication

Keywords

Diaphragm dysfunctionAcute respiratory failureWeaning

Outcome Measures

Primary Outcomes (1)

  • Diaphragm dysfunction

    Diaphragm dysfunction will be defined as maximal transdiaphragmatic pressure \< 30 cm H2O and/or maximal diaphragm thickening fraction \< 20% at study completion

    7 days

Secondary Outcomes (4)

  • Diaphragm thickness

    7 days

  • Diaphragm neuromuscular coupling

    7 days

  • Duration of inactivity (hours)

    7 days

  • Patient-ventilator asynchrony rate

    7 days

Study Arms (1)

Acute respiratory failure

We are enrolling patients who are intubated because of acute respiratory distress syndrome, pneumonia, septic shock, or severe acute brain injury (GCS ≤ 8 prior to intubation). This population is targeted for study because they are at relatively high risk of requiring prolonged mechanical ventilation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients who are receiving invasive mechanical ventilation for less than 36 hours.

You may qualify if:

  • Adult patients (\>18) with acute respiratory failure receiving invasive mechanical ventilation for less than 36 hours diagnosed with any of the following conditions: acute severe brain injury; moderate or severe ARDS; septic shock; pneumonia

You may not qualify if:

  • Predicted probability of remaining alive and on the ventilator on ICU day 7 is less than 50%
  • Liberation from mechanical ventilation is expected/planned within 24 hours
  • High cervical spine injury (C5 or higher)
  • Receiving mechanical ventilation for neuromuscular disease
  • Acute exacerbation of an obstructive lung disease
  • Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
  • Esophageal, gastric or duodenal surgical procedures within the last 6 months
  • Received mechanical ventilation for \> 48 hours in the preceding 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (4)

  • 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: 20813887BACKGROUND

  • 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: 18367735BACKGROUND

  • Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

    PMID: 26167730RESULT

  • Coiffard B, Dianti J, Telias I, Brochard LJ, Slutsky AS, Beck J, Sinderby C, Ferguson ND, Goligher EC. Dyssynchronous diaphragm contractions impair diaphragm function in mechanically ventilated patients. Crit Care. 2024 Apr 2;28(1):107. doi: 10.1186/s13054-024-04894-3.

    PMID: 38566126DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Ewan C Goligher, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intensivist

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 11, 2017

Study Start

June 25, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)