ClinicalTrials.Veeva

Menu

Electromyography for Diaphragm Effort (Edi2Pdi)

A

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Weaning Failure
Physiological Stress
Muscle Weakness
Diaphragm Injury

Treatments

Other: Inspiratory threshold loading protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT03580720
NL64648.029.18

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Intervention
Experimental group
Description:
Intervention group, receiving Inspiratory threshold loading protocol.
Treatment:
Other: Inspiratory threshold loading protocol

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems