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

NCT ID: NCT04459429

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-26
• Study Completion Date: 2020-12-24

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.

Conditions

RDS - Infants; TTN

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NHF by smaller cannula

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

Group Type: EXPERIMENTAL

Change of cannula size

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Change of cannula size

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Erebouni Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Pavel Mazmanyan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pavel Mazmanyan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erebouni Medical Center

Locations

Erebouni Medical Center Maternity

Yerevan, , Armenia

Countries

Armenia

Other Identifiers

Erebouni01Neonatal

Identifier Type: -

Identifier Source: org_study_id