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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03108118
Other study ID # 12-5582-B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2013
Est. completion date December 2019

Study information

Verified date January 2020
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Multiple factors are responsible for injury to the diaphragm during mechanical ventilation and critical illness. Suppression of respiratory drive and respiratory muscle activity can contribute to diaphragm dysfunction and increase the risk of prolonged mechanical ventilation.

The objective of this study is to determine whether diaphragm inactivity or injurious loading of hte diaphragm during mechanical ventilation leads to the development of diaphragm weakness. To address this question, we are monitoring the diaphragm longitudinally over the first week of mechanical ventilation.

Diaphragm activity is monitored by measurements of transdiaphragmatic pressure and diaphragm electrical activity. Diaphragm function is assessed by maximal transdiaphragmatic pressure generation and by measurements of diaphragm neuromuscular coupling. Diaphragm structure is assessed by daily ultrasound imaging.

Study measurments commence at enrolment (within 36 hours of intubation) and continue for the first 7 days of the study (or until extubation or death, if earlier).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Mount Sinai Hospital Toronto Ontario
Canada University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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 — 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Diaphragm thickness 7 days
Secondary Diaphragm neuromuscular coupling 7 days
Secondary Duration of inactivity (hours) 7 days
Secondary Patient-ventilator asynchrony rate 7 days
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