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

Effect of Cannula Size on Peripheral Oxygen Saturation During Nasal High Flow Therapy in Neonates With Respiratory Distress

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.

Study Overview

• Status: Completed
• Conditions: TTN; RDS - Infants
• Intervention / Treatment: Device: Change of cannula size

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia, 0087
    • Erebouni Medical Center Maternity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NHF by smaller cannula; Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula	Device: Change of cannula size; 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
EXPERIMENTAL: NHF by larger cannula; Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula	Device: Change of cannula size; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	1.5 hour
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	1.5 hour
Pulse rate	The difference in pulse rate between the period of using the larger cannula versus the smaller cannula	1.5 hour
Transcutaneous carbon dioxide	The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula	1.5 hour
Transcutaneous oxygen	The difference in TcO2 between the period of using the larger cannula versus the smaller cannula	1.5 hour

Collaborators and Investigators

• Sponsor: Erebouni Medical Center
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Pavel Mazmanyan, MD, PhD, Erebouni Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2020
• Primary Completion (ACTUAL): December 24, 2020
• Study Completion (ACTUAL): December 24, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Newborn; RDS; TTN; Nasal High Flow Therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Hyaline Membrane Disease
• Other Study ID Numbers: Erebouni01Neonatal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no intent to share individual data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No