Clinical trial NCT04459429: Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns
Official title: Effect of Cannula Size on Peripheral Oxygen Saturation During Nasal High Flow Therapy in Neonates With Respiratory Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RDS - Infants
TTN
Keywords: RDS
TTN
Nasal High Flow Therapy
Newborn
Lead sponsor: Erebouni Medical Center
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2020-07-07
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral oxygen saturation (SpO2 )
timeFrame: 1.5 hour
Secondary outcomes:
measure: inspiratory effort
timeFrame: 1.5 hour
measure: Respiratory rate
timeFrame: 1.5 hour
measure: Relative minute ventilation
timeFrame: 1.5 hour
measure: Pulse rate
timeFrame: 1.5 hour
measure: Transcutaneous carbon dioxide
timeFrame: 1.5 hour
measure: Transcutaneous oxygen
timeFrame: 1.5 hour
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Erebouni Medical Center Maternity
Study officials:
affiliation: Erebouni Medical Center
name: Pavel Mazmanyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: