HFNC Flow Titration and Effort of Breathing in the PICU

NCT ID: NCT02793674

Last Updated: 2024-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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High Flow Nasal Cannula

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fisher & Paykel high flow nasal cannula

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.

Group Type OTHER

Fisher & Paykel high flow nasal cannula

Intervention Type DEVICE

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.

Vapotherm high flow nasal cannula

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.

Group Type OTHER

Vapotherm high flow nasal cannula

Intervention Type DEVICE

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.

Interventions

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Fisher & Paykel high flow nasal cannula

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

Vapotherm high flow nasal cannula

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

Eligibility Criteria

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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.
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Robinder Khemani

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Related Links

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

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

Other Identifiers

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CHLA-14-00239

Identifier Type: -

Identifier Source: org_study_id

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