Effect of Cannula Size on Oxygen Saturation During Nasal... | NCT04459429

Studies
Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns

NCT04459429

Sponsor

Erebouni Medical Center

Status

Completed

Last Update Posted

Jun 30, 2021Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

RDS - Infants
TTN

Interventions

Change of cannula size

Countries

Armenia

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

Jun 2021

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

Jun 26, 2020Actual

Primary Completion Date

Dec 24, 2020Actual

Completion Date

Dec 24, 2020Actual

First Submitted Date

Jul 1, 2020

First Submission Date that Met QC Criteria

Jul 1, 2020

First Posted Date

Jul 7, 2020Actual

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

Jun 29, 2021

Last Update Posted Date

Jun 30, 2021Actual

Name	Class
Fisher and Paykel Healthcare	INDUSTRY

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

Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns.

Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure.

To the best of our knowledge, this is the first study to investigate the effect of using different NHF cannula size on peripheral oxygen saturation in newborns with respiratory distress.

Detailed Description

NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal cannula. The study will have a randomized crossover design. The larger or smaller cannula size will be applied as the first intervention during each experiment. During each experiment, if the larger cannula is applied first, then the smaller cannula will be applied second and if the smaller cannula is applied first, then the larger cannula will be applied second. Each experiment will last for 1.5 hour.

During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental oxygen will be set for the entire experiment unless there is a significant change in SpO2 as determined by the attending consultant.
There will be three consecutive 30-min periods of recording during each experiment and each experiment will last approximately 1.5 hour.
Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and transcutaneous carbon dioxide and oxygen.
Recordings will be made using ADInstruments Powerlab and Labchart software with video recording of the patient.
Routine measurement of heart rate, respiratory rate and oxygen saturations will be performed as per standard neonatal practice.

The researcher is an experienced neonatal consultant who will be directly observing the baby throughout the study.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NHF by smaller cannula	Experimental	Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula	Device: Change of cannula size
NHF by larger cannula	Experimental	Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula	Device: Change of cannula size

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Change of cannula size	Device	During nasal High Flow Therapy with fixed flow of 8 l/min, the cannula size will be changed from smaller-to-larger or larger-to-smaller	NHF by larger cannula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peripheral oxygen saturation (SpO2 )	The difference in SpO2 between the period of using the larger cannula versus the smaller cannula	1.5 hour

Secondary Outcomes

Measure	Description	Time Frame
inspiratory effort	The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula	1.5 hour
Respiratory rate	The change in respiratory rate between the period of using the larger cannula versus the smaller cannula

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Term and near term newborns with respiratory distress receiving treatment with NHF
≤ 48 hours old
FiO2 ≥ 0,4
Written parental informed consent

Exclusion Criteria:

Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician (meet nHF failure criteria).
Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
A parent has not given written informed consent to their baby's participation.
Prior intubation and/or surfactant administration
Known or suspected hypoxic ischemic encephalopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

2 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pavel Mazmanyan, MD, PhD	Erebouni Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erebouni Medical Center Maternity		Yerevan		0087	Armenia

IPD Sharing Statement Module

Plan to Share IPD

Description

There is currently no intent to share individual data with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C538359	RDS - infants

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided