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

Primary Purpose

RDS - Infants, TTN

Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
Change of cannula size
Sponsored by
Erebouni Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RDS - Infants focused on measuring RDS, TTN, Nasal High Flow Therapy, Newborn

Eligibility Criteria

1 Hour - 2 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Term and near term newborns with respiratory distress receiving treatment with NHF
  2. ≤ 48 hours old
  3. FiO2 ≥ 0,4
  4. Written parental informed consent

Exclusion Criteria:

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

Sites / Locations

  • Erebouni Medical Center Maternity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NHF by smaller cannula

NHF by larger cannula

Arm Description

Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula

Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula

Outcomes

Primary Outcome Measures

Peripheral oxygen saturation (SpO2 )
The difference in SpO2 between the period of using the larger cannula versus the smaller cannula

Secondary Outcome Measures

inspiratory effort
The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula
Respiratory rate
The change in respiratory rate between the period of using the larger cannula versus the smaller cannula
Relative minute ventilation
The difference in relative minute ventilation (inspiratory effort x respiratory rate) during the periods of using the larger cannula versus smaller cannula
Pulse rate
The difference in pulse rate between the period of using the larger cannula versus the smaller cannula
Transcutaneous carbon dioxide
The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula
Transcutaneous oxygen
The difference in TcO2 between the period of using the larger cannula versus the smaller cannula

Full Information

First Posted
July 1, 2020
Last Updated
June 29, 2021
Sponsor
Erebouni Medical Center
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04459429
Brief Title
Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns
Official Title
Effect of Cannula Size on Peripheral Oxygen Saturation During Nasal High Flow Therapy in Neonates With Respiratory Distress
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
December 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erebouni Medical Center
Collaborators
Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RDS - Infants, TTN
Keywords
RDS, TTN, Nasal High Flow Therapy, Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NHF by smaller cannula
Arm Type
Experimental
Arm Description
Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula
Arm Title
NHF by larger cannula
Arm Type
Experimental
Arm Description
Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula
Intervention Type
Device
Intervention Name(s)
Change of cannula size
Intervention Description
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
Primary Outcome Measure Information:
Title
Peripheral oxygen saturation (SpO2 )
Description
The difference in SpO2 between the period of using the larger cannula versus the smaller cannula
Time Frame
1.5 hour
Secondary Outcome Measure Information:
Title
inspiratory effort
Description
The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula
Time Frame
1.5 hour
Title
Respiratory rate
Description
The change in respiratory rate between the period of using the larger cannula versus the smaller cannula
Time Frame
1.5 hour
Title
Relative minute ventilation
Description
The difference in relative minute ventilation (inspiratory effort x respiratory rate) during the periods of using the larger cannula versus smaller cannula
Time Frame
1.5 hour
Title
Pulse rate
Description
The difference in pulse rate between the period of using the larger cannula versus the smaller cannula
Time Frame
1.5 hour
Title
Transcutaneous carbon dioxide
Description
The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula
Time Frame
1.5 hour
Title
Transcutaneous oxygen
Description
The difference in TcO2 between the period of using the larger cannula versus the smaller cannula
Time Frame
1.5 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Mazmanyan, MD, PhD
Organizational Affiliation
Erebouni Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erebouni Medical Center Maternity
City
Yerevan
ZIP/Postal Code
0087
Country
Armenia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no intent to share individual data with other researchers.

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

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