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Predicting Infant Extubation Using Diaphragm Surface Electromyography

NCT ID: NCT02878993

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-31

Brief Summary

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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.)

Detailed Description

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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.)

Conditions

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Infant, Newborn, Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intubated infants

Recording of diaphragm EMG

Recording of diaphragm EMG

Intervention Type DEVICE

Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography

Interventions

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Recording of diaphragm EMG

Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* intubated and mechanically ventilated on NICU

Exclusion Criteria

* major congenital abnormalities
Minimum Eligible Age

0 Days

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Greenough

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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King's College Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 32598319 (View on PubMed)

Other Identifiers

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16/LO/1281

Identifier Type: OTHER

Identifier Source: secondary_id

205807

Identifier Type: OTHER

Identifier Source: secondary_id

KCH16-100

Identifier Type: -

Identifier Source: org_study_id