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

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Erebouni Medical Center
Updated on 19 February 2024

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.

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.

Details
Condition RDS - Infants, TTN
Age 1years or below
Treatment Change of cannula size
Clinical Study IdentifierNCT04459429
SponsorErebouni Medical Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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