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Completed

NCT Number: NCT02878993

Predicting Infant Extubation Using Diaphragm Surface Electromyography

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.)

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Key information

Conditions

Infant, Newborn, Disease Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital

London, SE59RS, United Kingdom

About this study

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.)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • intubated and mechanically ventilated on NICU

Exclusion criteria

  • major congenital abnormalities

Treatment and study plan

Recording of diaphragm EMG

Device

Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography

Primary outcomes

  1. Magnitude of diaphragm EMG

    Time frame: One hour

    Magnitude of diaphragm EMG

  2. Ratio of diaphragm EMG to tidal volume

    Time frame: One hour

    Ratio of diaphragm EMG to tidal volume

Secondary outcomes

  1. Extubation success

    Time frame: 48 hours

    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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • King's College Hospital NHS Trust

Registry information

Acronym: EMG

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2016
Registry last updated
Nov 2, 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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