Diaphragm Injury and Dysfunction During Mechanical Ventilation

Respiratory Insufficiency Clinical Trial

— MYOTRAUMA  

Official title:

Diaphragm Injury and Dysfunction During Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108118
• Other study ID #: 12-5582-B
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diaphragm Injury
• Mechanical Ventilation Complication
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Wounds and Injuries

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