Electromyography for Diaphragm Effort

NCT03580720 | Completed

• 1 other identifier: NL64648.029.18
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm Injury; Muscle Weakness; Weaning Failure; Physiological Stress

Keywords

Monitoring; Breathing effort; Intensive Care; Diaphragm weakness

Outcome Measures

Primary Outcomes (2)

• Electrical activity of the diaphragm

  Diaphragm electromyography will be obtained with multiple electrode pairs situated on specialized esophageal catheters. The raw diaphragm electromyography will be filtered and integrated to obtain the compound mean action potential reported in microvolts (μV) as described in ref 1 (Sinderby et al.).

  Electrical activity of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.

• Transdiaphragmatic pressure

  The pressure gradient over the diaphragm will be obtained by subtracting the esophageal pressure from the pressure in the stomach, measured with specialized catheters, and will be reported in centimeters of water (cmH2O) as described in ref 3, American Thoracic Society (ATS) statement on respiratory muscle testing.

  Transdiaphragmatic pressure will be assessed at multiple levels of breathing effort in each subject for two hours.

Secondary Outcomes (4)

• Work of breathing

  Work of breathing will be assessed at multiple levels of breathing effort in each subject for two hours.

• Pressure-time product of the diaphragm

  Pressure-time product of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.

• Pressure-time product of the respiratory muscles

  Pressure-time product of the respiratory muscles will be assessed at multiple levels of breathing effort in each subject for two hours.

• Mechanical power

  Mechanical power will be assessed at multiple levels of breathing effort in each subject for two hours.

Other Outcomes (2)

• Accessory muscle recruitment

  Two hours.

• Diaphragm thickening fraction.

  Thickening fractions will be obtained at multiple levels of breathing effort in each subject for up to two hours

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention group, receiving Inspiratory threshold loading protocol.

Other: Inspiratory threshold loading protocol

Interventions

Inspiratory threshold loading protocol OTHER

Subjects will be instrumented with catheters that measure electrical activity of the diaphragm and transdiaphragmatic pressure. Subjects will perform a stepwise inspiratory threshold loading protocol to induce a wide range of diaphragm activity.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent
• Age \>18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081HV, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 9104877 BACKGROUND

• 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.

  PMID: 22476448 BACKGROUND

• 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.

  PMID: 12186831 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Angelique Spoelstra - de Man, MD, PhD

  Amsterdam UMC, location VUmc

  STUDY CHAIR

• Leo Heunks, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 9, 2018
• Study Start: May 16, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 30, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

NL (1)