Effects of High Flow Nasal Cannula on Deadspace Reduction and Regional Distribution of Ventilation

NCT02460653 | Unknown

• 1 other identifier: IRB-P00009490
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

1. 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. 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

Keywords

High flow nasal cannula; Oxygen therapy; Ventilation

Outcome Measures

Primary Outcomes (2)

• Oxygenation

  Improved oxygenation per flow rate category

  up to 3 hours

• Ventilation

  Lower respiratory rate or TCM CO2

  up to 3 hours

Secondary Outcomes (1)

• Regional distribution of ventilation

  up to 3 hours

Study Arms (4)

Current

NO INTERVENTION

Current level of HFNC support

Low

EXPERIMENTAL

Low flow range per kg.

Device: HFNC Flow Rate

Medium

EXPERIMENTAL

Medium flow range per kg.

Device: HFNC Flow Rate

High

EXPERIMENTAL

High flow range per kg

Device: HFNC Flow Rate

Interventions

HFNC Flow Rate DEVICE

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

High; Low; Medium

Eligibility Criteria

• Age: 4 Weeks - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Brian K Walsh, PhD, RRT

CONTACT

6179193692; brian.walsh@childrens.harvard.edu

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: Co-investigator

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: July 1, 2021
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

US (2)