Predicting Infant Extubation Using Diaphragm Surface Electromyography (EMG)

October 28, 2020 updated by: King's College London
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.)

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.)

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, SE59RS
        • King's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants mechanically ventilated on NICU without major congenital abnormalities

Description

Inclusion Criteria:

  • intubated and mechanically ventilated on NICU

Exclusion Criteria:

  • major congenital abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intubated infants
Recording of diaphragm EMG
Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of diaphragm EMG
Time Frame: One hour
Magnitude of diaphragm EMG
One hour
Ratio of diaphragm EMG to tidal volume
Time Frame: One hour
Ratio of diaphragm EMG to tidal volume
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne Greenough, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCH16-100
  • 16/LO/1281 (Other Identifier: NHS REC)
  • 205807 (IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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