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

NCT04459429 | Completed

• 1 other identifier: Erebouni01Neonatal
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

RDS - Infants; TTN

Keywords

RDS; TTN; Nasal High Flow Therapy; Newborn

Outcome Measures

Primary Outcomes (1)

• Peripheral oxygen saturation (SpO2 )

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

  1.5 hour

Secondary Outcomes (6)

• inspiratory effort

  1.5 hour

• Respiratory rate

  1.5 hour

• Relative minute ventilation

  1.5 hour

• Pulse rate

  1.5 hour

• Transcutaneous carbon dioxide

  1.5 hour

Study Arms (2)

NHF by smaller cannula

EXPERIMENTAL

Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula

Device: Change of cannula size

NHF by larger cannula

EXPERIMENTAL

Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula

Device: Change of cannula size

Interventions

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

NHF by larger cannula; NHF by smaller cannula

Eligibility Criteria

• Age: 1 Hour - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term and near term newborns with respiratory distress receiving treatment with NHF
• ≤ 48 hours old
• FiO2 ≥ 0,4
• Written parental informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Erebouni Medical Center: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Erebouni Medical Center Maternity

Yerevan, 0087, Armenia

Location

MeSH Terms

Conditions

RDS - infants

Study Officials

• Pavel Mazmanyan, MD, PhD

  Erebouni Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized crossover

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: June 26, 2020
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)