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HFNC Flow Titration and Effort of Breathing in the PICU (HFNCandEOB)

Primary Purpose

High Flow Nasal Cannula

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fisher & Paykel high flow nasal cannula

Vapotherm high flow nasal cannula

About this trial

This is an interventional treatment trial for High Flow Nasal Cannula focused on measuring effort of breathing, high flow nasal cannula, respiratory distress

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All participants less than or equal to three years old admitted to the PICU placed on high flow nasal cannula will be considered eligible for the study.

Exclusion Criteria:

Participants will be excluded if they have a corrected gestational age less than 37 weeks or contraindications to nasoesophageal catheter placement (nasopharyngeal or esophageal abnormalities) or RIP bands (abdominal wall defects such as omphalocele). Patients greater than three years of age will be excluded.

Sites / Locations

Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Fisher & Paykel high flow nasal cannula

Vapotherm high flow nasal cannula

Arm Description

All participants in the study were on one or two high flow nasal cannula (HFNC) delivery systems. All were measured on the Fisher & Paykel HFNC delivery system. The flow rate of the HFNC was adjusted to determine if there exists a change in their effort of breathing.

All participants in the study were on one or two high flow nasal cannula (HFNC) delivery systems. A subgroup was measured on the Vapotherm HFNC delivery system. The flow rate of the HFNC was adjusted to determine if there exists a change in their effort of breathing.

Outcomes

Primary Outcome Measures

Percent Change in Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)

PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute). The percent change in PRP is derived from the quotient of the absolute PRP at increased HFNC flow rates (1.0, 1.5, and 2.0 L/kg/min) divided by the absolute PRP at a baseline HFNC flow rate (0.5 L/kg/min). Percent change in PRP was used because a) there was a large degree of heterogeneity in baseline absolute PRP values in our study population based upon patient size, disease severity, and time point of illness, and b) we allowed for repeated measures on the same patient which would bias absolute PRP values in favor of those who were measured more frequently. It was not pre-specified to compare the two different HFNC delivery systems.

Secondary Outcome Measures

Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)

PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute). These values were obtained from 5 minute flow titration periods. For this outcome, the PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT). It was not pre-specified to compare the two different HFNC delivery systems.

Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)

Phase angle is a measure of asynchrony between thoracic and abdominal breathing compartments that has correlated with increased effort of breathing. It is derived by measuring the relative expansion of these two breathing compartments and describing the synchrony between them as an angle (theta). For this outcome, the phase angle was obtained for all titrations on both types of HFNC delivery system (FP and VT). It was not pre-specified to compare the two different HFNC delivery systems.

Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems

For this outcome, a subgroup of patients (N=12) were examined who had PRP measurements obtained on two different HFNC delivery systems (Fisher & Paykel (FP) and Vapotherm (VT)) in back-to-back flow titration periods. With one exception, patients were first studied on the FP and then transitioned to the VT HFNC delivery system.

Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)

To assess the relationship between patient size and dose-response of HFNC flow rate, we compared subgroups stratified by weight (patients <8 kg and >8 kg). For this outcome, the median percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT). It was not pre-specified to compare the two different HFNC delivery systems.

Maximum Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)

Exploratory analysis of patients by further stratified weight groupings (<5 kg, 5-8 kg, and >8 kg) was performed to determine the greatest observed benefit of HFNC flow titration in patients of different sizes. For this outcome, the maximum percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT). It was not pre-specified to compare the two different HFNC delivery systems.

Full Information

NCT ID

NCT02793674

First Posted

June 3, 2016

Last Updated

March 2, 2021

Sponsor

Children's Hospital Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT02793674

Brief Title

HFNC Flow Titration and Effort of Breathing in the PICU

Acronym

HFNCandEOB

Official Title

High-Flow Nasal Cannula Flow Titration and Effort of Breathing in the Pediatric Intensive Care Unit

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Los Angeles

4. Oversight

5. Study Description

Brief Summary

High-flow nasal cannula (HFNC) is a method of non-invasive respiratory support used to decrease the effort of breathing (EOB) in patients with a wide variety of respiratory diseases in the pediatric intensive care unit. While its use has shown association with decreased rates of mechanical ventilation, there is a paucity of data examining its direct effect upon objective measurements of EOB. This study will aim to evaluate objective measurements of EOB in response to different levels of HFNC support, characterize the natural course of respiratory diseases treated with HFNC, evaluate changes in EOB secondary to the administration of supplemental medical therapies used in conjunction with HFNC, and compare different physiologic metrics for quantifying EOB in patients on HFNC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Flow Nasal Cannula

Keywords

effort of breathing, high flow nasal cannula, respiratory distress

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fisher & Paykel high flow nasal cannula

Arm Type

Other

Arm Description

Arm Title

Vapotherm high flow nasal cannula

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Fisher & Paykel high flow nasal cannula

Intervention Description

Measurements of effort of breathing will be obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time will be allowed at each flow rate for stabilization of EOB and flow levels will be trialed in a random order, each being trialed for approximately 5 minutes.

Intervention Type

Device

Intervention Name(s)

Vapotherm high flow nasal cannula

Intervention Description

Primary Outcome Measure Information:

Title

Percent Change in Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)

Description

Time Frame

median percent change in PRP over 5 minute measurement period

Secondary Outcome Measure Information:

Title

Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)

Description

PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute). These values were obtained from 5 minute flow titration periods. For this outcome, the PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT). It was not pre-specified to compare the two different HFNC delivery systems.

Time Frame

median PRP over a 5 minute period

Title

Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)

Description

Time Frame

median phase angle over a 5 minute period

Title

Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems

Description

Time Frame

median PRP over a 5 minute period

Title

Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)

Description

Time Frame

medain percent change in PRP over a 5 minute period

Title

Maximum Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)

Description

Time Frame

median of the maximum percent change in PRP over a 5 minute period

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All participants less than or equal to three years old admitted to the PICU placed on high flow nasal cannula will be considered eligible for the study. Exclusion Criteria: Participants will be excluded if they have a corrected gestational age less than 37 weeks or contraindications to nasoesophageal catheter placement (nasopharyngeal or esophageal abnormalities) or RIP bands (abdominal wall defects such as omphalocele). Patients greater than three years of age will be excluded.

Facility Information:

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

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Links:

URL

http://dx.doi.org/10.1016/j.jpeds.2017.06.006

Description

Study Results: The Relationship between High Flow Nasal Cannula Flow Rate and Effort of Breathing in Children

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HFNC Flow Titration and Effort of Breathing in the PICU

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