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

Not Applicable

Completed

• Conditions: RDS - Infants; TTN
• Interventions: Device: Change of cannula size

• Registration Number: NCT04459429
• Lead Sponsor: Erebouni Medical Center

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.

Study Timeline

• Study Start: 2020-06-26
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Primary Completion: 2020-12-24
• Study Completion: 2020-12-24
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NHF by smaller cannula	Change of cannula size	Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula
NHF by larger cannula	Change of cannula size	Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula

Primary Outcome Measures

Name	Time	Method
Peripheral oxygen saturation (SpO2 )	1.5 hour	The difference in SpO2 between the period of using the larger cannula versus the smaller cannula

Secondary Outcome Measures

Name	Time	Method
Pulse rate	1.5 hour	The difference in pulse rate between the period of using the larger cannula versus the smaller cannula
Relative minute ventilation	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
Transcutaneous oxygen	1.5 hour	The difference in TcO2 between the period of using the larger cannula versus the smaller cannula
inspiratory effort	1.5 hour	The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula
Respiratory rate	1.5 hour	The change in respiratory rate between the period of using the larger cannula versus the smaller cannula
Transcutaneous carbon dioxide	1.5 hour	The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula

Trial Locations

Locations (1)

Erebouni Medical Center Maternity; 🇦🇲 Yerevan, Armenia