Recruiting

High Flow Nasal Cannula

Sponsor:

Boston Children's Hospital

Code:

NCT02460653

Conditions

Respiratory Insufficiency

Hypoxia

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

HFNC Flow Rate

Study Details

Brief summary:

1. To determine the lowest nasal cannula flow rate in which upper airway deadspace is reduced. Hypothesis - The lowest flow rate of high flow nasal cannula (HFNC) will reduce upper airway (extrathoracic) deadspace and improve respiratory efficiency by reducing transcutaneous CO2 and/or lower respiratory rate.
2. To determine the lowest nasal cannula flow rate in which regional distribution (as defined by EIT) of ventilation changes. Hypothesis - Moderate to high flow rates will create positive pressure that leads to improved regional distribution of ventilation.

Conditions

Respiratory Insufficiency

Hypoxia

Study ID

NCT02460653

Start date

May 1, 2015

Status verified date

Jun, 2019

Completion date

Jul 1, 2021

Anticipated

Primary completion date

Aug 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients who are receiving HFNC for hypoxia
  • Age: 1 day (> 38 weeks GA neonate or older) to 17 years.

Exclusion Criteria:

  • i. Patients who have congenital heart defects. ii. Patient who the medical team feels may require urgent escalation of non-invasive therapy or imminent intubation.

iii. Patients who are on FIO2 > 0.6 at the highest level of flow offered within the study.

iv. Patients who are immunocompromised and/or status post bone marrow transplant v. Patients who are on vasoactive support to maintain blood pressure or heart rate vi. Patients with a known airway anomaly, e.g. Pierre-Robin, tracheomalacia. vii. Patients less than 38 weeks gestational age viii. Patients less than 3 kilograms ix. If the EIT band/electrodes are not able to be properly positioned on the chest due to size/weight limitations x. If the medical team feels that the patient is not appropriate to enroll in the study based on medical, social or emotional concerns

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Current

Current level of HFNC support

experimental: Low

Low flow range per kg.

experimental: Medium

Medium flow range per kg.

experimental: High

High flow range per kg

Interventions

HFNC Flow Rate

We only change the flow rates between low, medium and high settings.

Primary outcome measure

  • Oxygenation [ Time Frame: up to 3 hours ]
  • Ventilation [ Time Frame: up to 3 hours ]

Central Contacts and Locations

Central contacts

Brian K Walsh, PhD, RRT

6179193692brian.walsh@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Brian K Walsh, RRT-NPS

617-919-3692brian.walsh@childrens.harvard.edu

Principal Investigator:

Jordan Rettig, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Robert DiBlasi, BS, RRT

robert.diblasi@seattlechildrens.org

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jun 4, 2019

Last verified

Jun, 2019

Keywords

  • High flow nasal cannula
  • Oxygen therapy
  • Ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2019-06-04.