Confirmation of Tube Placement in Newborns | NCT05229887

Studies
Confirmation of Tube Placement in Newborns

NCT05229887

Sponsor

University of Alberta

Status

Withdrawn

Last Update Posted

Sep 19, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Respiratory Distress Syndrome
Apnea of Newborn

Interventions

Nostril-Tragus-Length
Vocal cord marking

Countries

Canada

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

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

need to be redesigned

Expanded Access Info

Start Date

Jul 4, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Jan 31, 2022

First Submission Date that Met QC Criteria

Jan 31, 2022

First Posted Date

Feb 8, 2022Actual

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

Sep 11, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Tracheal intubation remains a common procedure in the neonatal intensive care unit (NICU) and the delivery room (DR).

Current guidelines recommend Estimation of correct endotracheal tube (ETT) insertion Our hospital policy recommends to estimate the correct depth (cm) of tube placement by measuring the nasal-ear-tragus length using the "7-8-9 rule" when the endotracheal tube is placed orally. Using this formula an infant weighing 1kg would be intubated to a depth of 7cm, a 2kg infant to a depth of 8cm, and a 3kg infant to a depth of 9cm from the upper lip.

With the new 2015 guidelines, ETT depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm or by using the "initial endotracheal tube insertion depth" table. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear.

However, studies using NTL reported that using this technique only resulted in correct ETT placement in 56% of cases.

Every ETT has markings on the tube, which are called vocal cord markings, which are to be used to provide a guidance to how deep to place the ETT into the trachea. There has been npc study to compare the vocal cord markings with the current approach of NTL.

The current study aims to determine if the use of vocal cord markings during intubation increases percentage of correct endotracheal tube placement compared to NTL in preterm and term infants.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nostril-Tragus-Length	Active Comparator		Procedure: Nostril-Tragus-Length
Vocal cord markings	Experimental		Procedure: Vocal cord marking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nostril-Tragus-Length	Procedure	Endotracheal tube depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of endotracheal tubes correctly placed within the trachea		within 30 minutes after endotracheal intubation

Secondary Outcomes

Measure	Description	Time Frame
Mortality in the Neonatal Intensive Care Unit	We will record the number of infants who die during their admission	0-200 days
Necrotizing Enterocolitis	We will record the number of infants who are diagnosed with Necrotizing Enterocolitis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or/and Neonatal Intensive Care Unit will be eligible.

Exclusion Criteria:

Infants will be excluded if their parents refuse to give consent to this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg Schmolzer	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Alexandra Hospital		Edmonton	Alberta	T5H 3V9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Investigators can contact the PI to discuss to use the collected data

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

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