Clinical trial NCT03580720: Electromyography for Diaphragm Effort
Official title: Diaphragm Electromyography to Estimate Breathing Effort: a Physiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragm Injury
Muscle Weakness
Weaning Failure
Physiological Stress
Keywords: Monitoring
Breathing effort
Intensive Care
Diaphragm weakness
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Mechanical ventilation may be necessary to save the life of a patient due to an accident, pneumonia or surgery. The ventilator then temporarily takes over the function of the respiratory muscles. During treatment in the Intensive Care, the amount of support provided by the ventilator is usually lowered gradually, until the point that the patient can breathe unassisted once again. However, in a large fraction of patients (up to 40%) it takes days to weeks before the patient is able to breathe unassisted, even after the initial disease has been treated. This is called prolonged weaning.

A possible cause of prolonged weaning is weakness of the respiratory muscles. The diaphragm, the largest respiratory muscle, can become weakened if it is used too little, much like all other muscles in the body. Additionally, damage and weakness of the diaphragm can occur when the diaphragm has to work excessively. Therefore, it is important that the diaphragm works enough; not so little that it becomes weakened, but not too much either.

Measurements of pressure generated by the diaphragm are needed to determine the current level of diaphragm activity in a patient on mechanical ventilation. However, these measurements are rarely performed, because they are time-consuming and require placement of two additional nasogastric catheters. This is a shame, as adequate loading of the diaphragm might prevent development of weakness, leading to shorter duration of mechanical ventilation. Finding alternative measurements of diaphragm effort might be a solution to this problem.

It has been hypothesized that the electrical activity of the diaphragm provides a reliable indication of diaphragm effort. This study aims to determine whether there is a correlation between pressure generation by the diaphragm and electrical activity of the diaphragm over a wide range of respiratory activity, from low effort to extreme effort, in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Age \>18 years

Exclusion Criteria:

* History of cardiac and/or pulmonary disease or current medication use
* History of pneumothorax
* Contra-indications for nasogastric tube placement (recent epistaxis, severe coagulopathy, current upper airway pathology)
* Contra-indication for magnetic stimulation (cardiac pacemakers or metal in cervical area)

Primary outcomes:
measure: Electrical activity of the diaphragm
timeFrame: Electrical activity of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
measure: Transdiaphragmatic pressure
timeFrame: Transdiaphragmatic pressure will be assessed at multiple levels of breathing effort in each subject for two hours.
Secondary outcomes:
measure: Work of breathing
timeFrame: Work of breathing will be assessed at multiple levels of breathing effort in each subject for two hours.
measure: Pressure-time product of the diaphragm
timeFrame: Pressure-time product of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
measure: Pressure-time product of the respiratory muscles
timeFrame: Pressure-time product of the respiratory muscles will be assessed at multiple levels of breathing effort in each subject for two hours.
measure: Mechanical power
timeFrame: Mechanical power will be assessed at multiple levels of breathing effort in each subject for two hours.
Other outcomes:
measure: Accessory muscle recruitment
timeFrame: Two hours.
measure: Diaphragm thickening fraction.
timeFrame: Thickening fractions will be obtained at multiple levels of breathing effort in each subject for up to two hours
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Angelique Spoelstra - de Man, MD, PhD
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Leo Heunks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinderby CA, Beck JC, Lindstrom LH, Grassino AE. Enhancement of signal quality in esophageal recordings of diaphragm EMG. J Appl Physiol (1985). 1997 Apr;82(4):1370-7. doi: 10.1152/jappl.1997.82.4.1370.
citation: Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
citation: American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.