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NCT02878993 Clinical Trial

Predicting Infant Extubation Using Diaphragm Surface Electromyography

Infant, Newborn, Disease Clinical Trial

— EMG  

Official title:
Predicting Infant Extubation Using Diaphragm Surface Electromyography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02878993
Other study ID # KCH16-100
Secondary ID 16/LO/1281205807
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date August 2018

Study information
Verified date March 2018
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Description:

This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date August 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility Inclusion Criteria: - intubated and mechanically ventilated on NICU Exclusion Criteria: - major congenital abnormalities

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Recording of diaphragm EMG
Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography

Locations
Country Name City State
United Kingdom King's College Hospital London

Sponsors (2)
Lead Sponsor Collaborator
King's College London King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Hunt KA, Hunt I, Ali K, Dassios T, Greenough A. Prediction of extubation success using the diaphragmatic electromyograph results in ventilated neonates. J Perinat Med. 2020 Jul 28;48(6):609-614. doi: 10.1515/jpm-2020-0129. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Magnitude of diaphragm EMG Magnitude of diaphragm EMG One hour
Primary Ratio of diaphragm EMG to tidal volume Ratio of diaphragm EMG to tidal volume One hour
Secondary Extubation success Extubation success is define as remaining free of invasive mechanical ventilation. Whether the above measures of diaphragm EMG can predict such success will be investigated 48 hours
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