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

• ClinicalTrials.gov Identifier: NCT02793674
• Recruitment Status: Completed
• First Posted: June 8, 2016
• Results First Posted: August 2, 2018
• Last Update Posted: March 4, 2021
• Sponsor: Children's Hospital Los Angeles
• Information provided by (Responsible Party): Children's Hospital Los Angeles

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.

Condition or disease	Intervention/treatment	Phase
High Flow Nasal Cannula	Device: Fisher & Paykel high flow nasal cannula; Device: Vapotherm high flow nasal cannula	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High-Flow Nasal Cannula Flow Titration and Effort of Breathing in the Pediatric Intensive Care Unit
• Study Start Date: September 2014
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
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.	Device: 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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: median percent change in PRP over 5 minute measurement period ]

   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 :

1. Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT) [ Time Frame: median PRP over a 5 minute period ]

   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.

2. Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT) [ Time Frame: median phase angle over a 5 minute period ]

   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.

3. Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems [ Time Frame: median PRP over a 5 minute period ]
   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.
4. 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) [ Time Frame: medain percent change in PRP over a 5 minute period ]

   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.

5. 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) [ Time Frame: median of the maximum percent change in PRP over a 5 minute period ]

   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.

Eligibility Criteria

• Ages Eligible for Study: up to 3 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Sponsors and Collaborators

Children's Hospital Los Angeles

More Information

Additional Information:

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

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• Responsible Party: Children's Hospital Los Angeles
• ClinicalTrials.gov Identifier: NCT02793674
• Other Study ID Numbers: CHLA-14-00239
• First Posted: June 8, 2016
• Results First Posted: August 2, 2018
• Last Update Posted: March 4, 2021
• Last Verified: July 2018

Keywords provided by Children's Hospital Los Angeles:

effort of breathing; high flow nasal cannula; respiratory distress

Additional relevant MeSH terms:

Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes