N/A
N=21
HFNC Flow Titration and Effort of Breathing in the PICU
High Flow Nasal Cannula
Bottom Line
View on ClinicalTrials.gov: NCT02793674 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: 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) — -10; -20; -23 percent change in PRP
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fisher & Paykel high flow nasal cannula (Device); Vapotherm high flow nasal cannula (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-10; -20; -23 | — |
| SECONDARY Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT) |
824; 699; 596; 594 | — |
| SECONDARY Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT) |
61; 61; 68; 59 | — |
| SECONDARY Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems |
-15; -9; -19; -22; -23; -11 | — |
| SECONDARY 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) |
-14; -5; -27; -2; -25; -15 | — |
| SECONDARY 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) |
-46; -30; -17 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02793674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.