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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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TTN, RDS - Infants

Intervention / Treatment
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* Device: Change of cannula size


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NHF by smaller cannula<br>Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula | Device: Change of cannula size<br>* 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<br>|
| Experimental: NHF by larger cannula<br>Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula | Device: Change of cannula size<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDS, TTN, Nasal High Flow Therapy, Newborn