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NCT Number: NCT03580720

Electromyography for Diaphragm Effort

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.

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Key information

Conditions

Diaphragm Injury Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Physiological Stress Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Weaning Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081HV, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Electrical activity of the diaphragm

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

    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.).

  2. Transdiaphragmatic pressure

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

    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.

Secondary outcomes

  1. Work of breathing

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

    Work of breathing will be obtained by integrating the pressure-volume loops of esophageal pressure and tidal volume, and will be reported in Joule per minute as described in ref 3, ATS statement on respiratory muscle testing..

  2. Pressure-time product of the diaphragm

    Time frame: 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 diaphragm will be obtained by dividing the time-integral of transdiaphragmatic pressure (described above) over time, and will be reported as cmH20*s per minute as described in ref 3, ATS statement on respiratory muscle testing..

  3. Pressure-time product of the respiratory muscles

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

    Pressure-time product of the respiratory muscles will be obtained by dividing the time-integral of esophageal pressure over time, and will be reported as cmH20*s per minute as described in ref 3, ATS statement on respiratory muscle testing..

  4. Mechanical power

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

    Mechanical power will be obtained by multiplying the work of breathing (described above) by the number of breaths per minute, and will be reported in Watt (joule/minute) as described in ref 3, ATS statement on respiratory muscle testing..

Other outcomes

  1. Accessory muscle recruitment

    Time frame: Two hours.

    As an explorative end-point, the timepoint at which several accessory inspiratory muscles are recruited during incremental respiratory loading will be studied and reported (if technically possible)

  2. Diaphragm thickening fraction.

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

    Using a linear probe positioned in the mid-axillary line the diaphragm will be visualized as per clinical protocol. Diaphragm thickness will be measured during inspiration and expiration and will be reported in mm. Thickening fraction will be obtained with the following formula: (Thickness during inspiration - thickness during expiration) / thickness during expiration * 100% as described in ref 2 (Vivier et al.).

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Diaphragm Electromyography to Estimate Breathing Effort: a Physiological Study

Acronym: Edi2Pdi

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2018
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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