- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02878993
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
Conditions
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.
Sponsor
Collaborators
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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