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

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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition High Flow Nasal Cannula
Interventions Device: Fisher & Paykel high flow nasal cannula
Device: Vapotherm high flow nasal cannula
Enrollment 21
Recruitment Details This study screened patients admitted to the PICU during the study period (September 2014 to June 2016) who were <3 years of age and started on high flow nasal cannula by the clinical team.
Pre-assignment Details Of the 54 patients who met eligibility criteria on screening, 39% (N=21) underwent high flow nasal cannula flow titrations and had effort of breathing measurements taken.
Arm/Group Title Fisher & Paykel (FP) HFNC Vapotherm (VT) HFNC
Hide Arm/Group Description

A subgroup of participants were placed exclusively on Fisher & Paykel (FP) high flow nasal cannula (HFNC) (N=9). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.

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

A subgroup of patients (N=12) had flow titrations performed on both Fisher & Paykel (FP) and Vapotherm (VT) high flow nasal cannula (HFNC) delivery systems. The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions. These patients had flow titrations on both HFNC delivery systems performed to compare EOB on these two different HFNC delivery systems. With one exception, titrations were performed on FP first, then crossed over to VT.

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

Period Title: Overall Study
Started 9 12
Completed 9 12
Not Completed 0 0
Arm/Group Title Fisher & Paykel (FP) HFNC Vapotherm (VT) HFNC Total
Hide Arm/Group Description

A subgroup was studied on Fisher & Paykel (FP) high flow nasal cannula (HFNC) exclusively (N=9). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.

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

A subgroup was studied on Vapotherm (VT) high flow nasal cannula (HFNC) (N=12). These patients then crossed over to the other arm and had back-to-back titrations on both types of HFNC (FP and VT). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.

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

Total of all reporting groups
Overall Number of Baseline Participants 9 12 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 9 participants 12 participants 21 participants
15
(5 to 25)
4
(2 to 6)
6
(2 to 12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 21 participants
Female
4
  44.4%
5
  41.7%
9
  42.9%
Male
5
  55.6%
7
  58.3%
12
  57.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity / Race Number Analyzed 9 participants 12 participants 21 participants
African-American
0
   0.0%
2
  16.7%
2
   9.5%
Hispanic
6
  66.7%
9
  75.0%
15
  71.4%
Not specified
3
  33.3%
1
   8.3%
4
  19.0%
Weight  
Median (Inter-Quartile Range)
Unit of measure:  Kilograms
Number Analyzed 9 participants 12 participants 21 participants
9
(6.4 to 11)
6.5
(4.8 to 7)
6.5
(5 to 9)
Respiratory Illness  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 21 participants
Bronchiolitis 6 7 13
Pneumonia 2 0 2
Other 1 5 6
1.Primary Outcome
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)
Hide 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).

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.

Time Frame median percent change in PRP over 5 minute measurement period
Hide Outcome Measure Data
Hide Analysis Population Description
For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.
Arm/Group Title Percent Change in Pressure-Rate Product
Hide Arm/Group Description:

All participants in the study were placed on high flow nasal cannula (HFNC). For this outcome, the median percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).

The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.

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

Overall Number of Participants Analyzed 21
Median (Inter-Quartile Range)
Unit of Measure: percent change in PRP
Percent Change in PRP at 1.0 L/kg/min
-10
(-22 to 0)
Percent Change in PRP at 1.5 L/kg/min
-20
(-35 to -3.5)
Percent Change in PRP at 2.0 L/kg/min
-23
(-33 to -9.0)
2.Secondary Outcome
Title Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.
Arm/Group Title Pressure-Rate Product
Hide Arm/Group Description:

All participants in the study were placed on high flow nasal cannula (HFNC). or this outcome, the PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.

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

Overall Number of Participants Analyzed 21
Median (Inter-Quartile Range)
Unit of Measure: cmH20 * breaths/minute
PRP at 0.5 L/kg/min
824
(592 to 1252)
PRP at 1.0 L/kg/min
699
(461 to 1080)
PRP at 1.5 L/kg/min
596
(406 to 923)
PRP at 2.0 L/kg/min
594
(365 to 893)
3.Secondary Outcome
Title Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)
Hide Description

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.

Time Frame median phase angle over a 5 minute period
Hide Outcome Measure Data
Hide Analysis Population Description
For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.
Arm/Group Title Phase Angle
Hide Arm/Group Description:
The phase angle was measured at all flow titrations for all patients on both types of HFNC delivery systems (FP and VT). This is a measure of thoracoabdominal asynchrony and a proxy for effort of breathing.
Overall Number of Participants Analyzed 21
Median (Inter-Quartile Range)
Unit of Measure: degrees
0.5 L/kg/min
61
(40 to 115)
1.0 L/kg/min
61
(38 to 120)
1.5 L/kg/min
68
(38 to 122)
2.0 L/kg/min
59
(34 to 138)
4.Secondary Outcome
Title Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems
Hide Description 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.
Time Frame median PRP over a 5 minute period
Hide Outcome Measure Data
Hide Analysis Population Description
Percent change in PRP from baseline (of 0.5 L/kg/min) was measured at different flow rates (1.0, 1.5, and 2.0 L/kg/min) for patients who had flow titrations done on the two different HFNC delivery systems (Fisher & Paykel (FP) and Vapotherm (VT)).
Arm/Group Title Fisher & Paykel HFNC Delivery System Vapotherm HFNC Delivery System
Hide Arm/Group Description:
This arm shows the outcome (the median of the percent change in PRP from baseline as a function of flow rate) for these patients when they were studied on the FP HFNC delivery system.
This arm shows the outcome (the median of the percent change in PRP from baseline as a function of flow rate) for these patients when they were studied on the VT HFNC delivery system.
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: percent change in PRP
1.0 L/kg/min
-15
(-22 to -5)
-9
(-18 to 4)
1.5 L/kg/min
-19
(-42 to -7)
-22
(-30 to 2)
2.0 L/kg/min
-23
(-36 to -17)
-11
(-32 to 8)
5.Secondary Outcome
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)
Hide Description

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.

Time Frame medain percent change in PRP over a 5 minute period
Hide Outcome Measure Data
Hide Analysis Population Description
For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.
Arm/Group Title Less Than or Equal to 8 kg Greater Than 8 kg
Hide Arm/Group Description:
The percent change in Pressure-rate Product (PRP) from baseline as a function of increasing HFNC flow rate was analyzed comparing weight-stratified subgroups. This analysis looked at the first titration performed on the HFNC delivery system for patients less than or equal to 8 kg (12 patients, 20 episodes) and greater than 8 kg (9 patients, 12 episodes). This outcome was derived from flow titraitons on both types of HFNC delivery system (FP and VT).
The percent change in Pressure-rate Product (PRP) from baseline as a function of increasing HFNC flow rate was analyzed comparing weight-stratified subgroups. This analysis looked at the first titration performed on the HFNC delivery system for patients less than or equal to 8 kg (12 patients, 20 episodes) and greater than 8 kg (9 patients, 12 episodes). This outcome was derived from flow titraitons on both types of HFNC delivery system (FP and VT).
Overall Number of Participants Analyzed 12 9
Median (Inter-Quartile Range)
Unit of Measure: percent change in PRP from baseline
1.0 L/kg/min
-14
(-23 to 0)
-5
(-10 to 3)
1.5 L/kg/min
-27
(-44 to -5)
-2
(-22 to 5)
2.0 L/kg/min
-25
(-45 to -16)
-15
(-29 to -8)
6.Secondary Outcome
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)
Hide Description

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.

Time Frame median of the maximum percent change in PRP over a 5 minute period
Hide Outcome Measure Data
Hide Analysis Population Description
For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.
Arm/Group Title Maximum Percent Change in PRP From Baseline Stratified by Wt
Hide Arm/Group Description:
This analysis looked at the largest decrease in PRP for all flow titrations for weight stratified subgroups. For this outcome, the maximum percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).
Overall Number of Participants Analyzed 21
Median (Inter-Quartile Range)
Unit of Measure: percent
<5 kg
-46
(-52 to -29)
5-8 kg
-30
(-48 to -6)
>8 kg
-17
(-33 to 6)
Time Frame 22 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fisher & Paykel (FP) High Flow Nasal Cannula Vapotherm (VT) High Flow Nasal Cannula
Hide Arm/Group Description A subgroup was studied on Fisher & Paykel (FP) high flow nasal cannula (HFNC) exclusively (N=9). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions. A subgroup was studied on Vapotherm (VT) high flow nasal cannula (HFNC) (N=12). These patients then crossed over to the other arm and had back-to-back titrations on both types of HFNC (FP and VT). The flow rate of the HFNC was adjusted to determine if there existed a change in their effort of breathing (EOB) at different conditions.
All-Cause Mortality
Fisher & Paykel (FP) High Flow Nasal Cannula Vapotherm (VT) High Flow Nasal Cannula
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Fisher & Paykel (FP) High Flow Nasal Cannula Vapotherm (VT) High Flow Nasal Cannula
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fisher & Paykel (FP) High Flow Nasal Cannula Vapotherm (VT) High Flow Nasal Cannula
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/12 (0.00%)    
Product Issues     
any adverse event   0/21 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Weiler, MD
Organization: Presbyterian Hospital
Phone: 505-724-7044
EMail: tweiler@gmail.com
Publications:
Layout table for additonal information
Responsible Party: Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT02793674     History of Changes
Other Study ID Numbers: CHLA-14-00239
First Submitted: June 3, 2016
First Posted: June 8, 2016
Results First Submitted: November 6, 2017
Results First Posted: August 2, 2018
Last Update Posted: August 2, 2018