Predicting Infant Extubation Using Diaphragm Surface Elec... | NCT02878993

Studies
Predicting Infant Extubation Using Diaphragm Surface Electromyography

NCT02878993

Sponsor

King's College London

Status

Completed

Last Update Posted

Nov 2, 2020Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Infant, Newborn, Disease

Interventions

Recording of diaphragm EMG

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
16/LO/1281	Other Identifier	NHS REC
205807	Other Identifier	IRAS

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

May 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Aug 22, 2016

First Posted Date

Aug 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2020

Last Update Posted Date

Nov 2, 2020Actual

Name	Class
King's College Hospital NHS Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.)

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intubated infants		Recording of diaphragm EMG	Device: Recording of diaphragm EMG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recording of diaphragm EMG	Device	Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography	Intubated infants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

intubated and mechanically ventilated on NICU

Exclusion Criteria:

major congenital abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

12 Months

Standard Ages

Child

Study Population

Infants mechanically ventilated on NICU without major congenital abnormalities

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Greenough	King's College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King's College Hospital		London		SE59RS	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32598319	Background	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms