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Completed

NCT Number: NCT04459429

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

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.

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Key information

Conditions

RDS - Infants TTN

Age range

1 hour–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erebouni Medical Center Maternity

Yerevan, 0087, Armenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Peripheral oxygen saturation (SpO2 )

    Time frame: 1.5 hour

    The difference in SpO2 between the period of using the larger cannula versus the smaller cannula

Secondary outcomes

  1. inspiratory effort

    Time frame: 1.5 hour

    The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula

  2. Respiratory rate

    Time frame: 1.5 hour

    The change in respiratory rate between the period of using the larger cannula versus the smaller cannula

  3. Relative minute ventilation

    Time frame: 1.5 hour

    The difference in relative minute ventilation (inspiratory effort x respiratory rate) during the periods of using the larger cannula versus smaller cannula

  4. Pulse rate

    Time frame: 1.5 hour

    The difference in pulse rate between the period of using the larger cannula versus the smaller cannula

  5. Transcutaneous carbon dioxide

    Time frame: 1.5 hour

    The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula

  6. Transcutaneous oxygen

    Time frame: 1.5 hour

    The difference in TcO2 between the period of using the larger cannula versus the smaller cannula

Sponsors and collaborators

Lead sponsor

Erebouni Medical Center

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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