search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Measuring electrical activity of the diaphragm on the ICU


- candidate number19389
- NTR NumberNTR4766
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-sep-2014
- Secondary IDsNL50006.018.14 METC AMC Amsterdam
- Public TitleMeasuring electrical activity of the diaphragm on the ICU
- Scientific TitleSurface electromyography of the diaphragm on the intensive care unit: a pilot study
- ACRONYMSEDICU
- hypothesis-Surface electromyography (sEMG) of the diaphragm can detect patient-ventilator dyssynchrony
-sEMG of the diaphragm correlates with the Eadi signals of a transesophageal EMG catheter
-sEMG changes with increased physical activity on the ICU
-sEMG fatigue parameters correlate with clinical parameters of fatigue during weaning from mechanical ventilation
- Healt Condition(s) or Problem(s) studiedElectromyography, Muscle weakness, Mechanical ventilation
- Inclusion criteria-Consecutive patients admitted to the ICU of the Academic Medical Center Amsterdam
-Age ≥ 18 years
-Expected duration of mechanical ventilation for ≥ 48 hours
-Informed consent
- Exclusion criteria-(Suspected) neuromuscular disease (other than ICU-AW) or cervical spinal cord injury
-Known phrenic nerve injury
-Contraindication for electrode placement (e.g. severe skin infection at electrode site)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 8-sep-2014
- planned closingdate8-sep-2015
- Target number of participants120
- InterventionsSurface electromyography of the diaphragm and intercostal muscles
- Primary outcome-Correlation of transcutaneous sEMG of the diaphragm with airway pressure and flow to detect -patient ventilator dyssynchrony
-Correlation of transcutaneous sEMG of the diaphragm with EAdi signal of NAVA catheter.
-Changes in sEMG signals during increased physical activity
-Correlation of sEMG fatigue parameters with clinical parameters of fatigue during weaning from mechanical ventilation
- Secondary outcomeFeasibility of sEMG on the ICU
- TimepointsRecordings of 15 minutes to maximum 4 hours (depending on research question)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. Janneke Horn
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Janneke Horn
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryPatients on the intensive care unit often need mechanical ventilation. Mechanical ventilation is harmful for the diaphragm. This leads to diaphragmatic dysfunction and weakness. One of the causes is patient-ventilator dyssynchrony (PVD). PVD is a frequent problem on the ICU, but detection demands expertise and time. PVD can lead to prolonged mechanical ventilation and ICU stay. In patients with diaphragmatic weakness, weaning from mechanical ventilation has to be done carefully. This time-consuming process leads to a prolonged stay on the ICU, which is associated with an increased risk of infections, mortality and increased costs.
Optimized monitoring of diaphragm function might be able to detect patient-ventilator dyssynchrony and might accelerate the weaning process and diminish the length of mechanical ventilation and ICU stay.
The electrical activity of the diaphragm (EAdi) can be detected by three electromyography (EMG) methods: transcutaneous EMG, intramuscular EMG and transesophageal EMG. Transcutaneous electromyography, also called surface electromyography (sEMG), is the least invasive method. In this pilot study we aim to investigate the additional value of sEMG signals of respiratory muscles during ICU admission in adults.
- Main changes (audit trail)
- RECORD3-sep-2014 - 1-okt-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl