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

TTN Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459429
• Other study ID #: Erebouni01Neonatal
• Status: Completed
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: December 24, 2020

Study information

• Verified date: June 2021
• Source: Erebouni Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 24, 2020
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• RDS - Infants
• TTN

Intervention

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

Locations

Country	Name	City	State
Armenia	Erebouni Medical Center Maternity	Yerevan

Sponsors (2)

Lead Sponsor	Collaborator
Erebouni Medical Center	Fisher and Paykel Healthcare

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral oxygen saturation (SpO2 )	The difference in SpO2 between the period of using the larger cannula versus the smaller cannula	1.5 hour
Secondary	inspiratory effort	The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula	1.5 hour
Secondary	Respiratory rate	The change in respiratory rate between the period of using the larger cannula versus the smaller cannula	1.5 hour
Secondary	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
Secondary	Pulse rate	The difference in pulse rate between the period of using the larger cannula versus the smaller cannula	1.5 hour
Secondary	Transcutaneous carbon dioxide	The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula	1.5 hour
Secondary	Transcutaneous oxygen	The difference in TcO2 between the period of using the larger cannula versus the smaller cannula	1.5 hour