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Electromyography for Diaphragm Effort (Edi2Pdi)

Primary Purpose

Diaphragm Injury, Muscle Weakness, Weaning Failure

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Inspiratory threshold loading protocol
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diaphragm Injury focused on measuring Monitoring, Breathing effort, Intensive Care, Diaphragm weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Amsterdam UMC, location VUmc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Intervention group, receiving Inspiratory threshold loading protocol.

Outcomes

Primary Outcome Measures

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.).
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.

Secondary Outcome Measures

Work of breathing
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..
Pressure-time product of the diaphragm
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..
Pressure-time product of the respiratory muscles
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..
Mechanical power
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..

Full Information

First Posted
June 8, 2018
Last Updated
May 19, 2020
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT03580720
Brief Title
Electromyography for Diaphragm Effort
Acronym
Edi2Pdi
Official Title
Diaphragm Electromyography to Estimate Breathing Effort: a Physiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm Injury, Muscle Weakness, Weaning Failure, Physiological Stress
Keywords
Monitoring, Breathing effort, Intensive Care, Diaphragm weakness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group, receiving Inspiratory threshold loading protocol.
Intervention Type
Other
Intervention Name(s)
Inspiratory threshold loading protocol
Intervention Description
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 Outcome Measure Information:
Title
Electrical activity of the diaphragm
Description
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.).
Time Frame
Electrical activity of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
Title
Transdiaphragmatic pressure
Description
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.
Time Frame
Transdiaphragmatic pressure will be assessed at multiple levels of breathing effort in each subject for two hours.
Secondary Outcome Measure Information:
Title
Work of breathing
Description
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..
Time Frame
Work of breathing will be assessed at multiple levels of breathing effort in each subject for two hours.
Title
Pressure-time product of the diaphragm
Description
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..
Time Frame
Pressure-time product of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
Title
Pressure-time product of the respiratory muscles
Description
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..
Time Frame
Pressure-time product of the respiratory muscles will be assessed at multiple levels of breathing effort in each subject for two hours.
Title
Mechanical power
Description
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..
Time Frame
Mechanical power will be assessed at multiple levels of breathing effort in each subject for two hours.
Other Pre-specified Outcome Measures:
Title
Accessory muscle recruitment
Description
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)
Time Frame
Two hours.
Title
Diaphragm thickening fraction.
Description
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.).
Time Frame
Thickening fractions will be obtained at multiple levels of breathing effort in each subject for up to two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelique Spoelstra - de Man, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leo Heunks, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC, location VUmc
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HV
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9104877
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.
Results Reference
background
PubMed Identifier
22476448
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.
Results Reference
background
PubMed Identifier
12186831
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.
Results Reference
background

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Electromyography for Diaphragm Effort

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