High Flow Nasal CannulaHFNCandEOBNCT02793674

HFNC Flow Titration and Effort of Breathing in the PICU

A study testing Fisher & Paykel high flow nasal cannula and Vapotherm high flow nasal cannula in people with High Flow Nasal Cannula, run by Children's Hospital Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages Up to 3 years
Conditions the study is for: High Flow Nasal Cannula
What is being tested?: Fisher & Paykel high flow nasal cannula and Vapotherm high flow nasal cannula
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital Los Angeles
Los Angeles, California, 90027

Other trials in United States

About this study

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

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.

Conditions: High Flow Nasal Cannula
Being tested: Fisher & Paykel high flow nasal cannula, Vapotherm high flow nasal cannula
Keywords: effort of breathing, high flow nasal cannula, respiratory distress
Medical subject headings: Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fisher & Paykel high flow nasal cannulaDevice
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 cannulaDevice
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.

Study groups in NCT02793674
Study group	Role	What they receive
Fisher & Paykel high flow nasal cannula	Other	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. Receives: Device: Fisher & Paykel high flow nasal cannula
Vapotherm high flow nasal cannula	Other	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. Receives: Device: Vapotherm high flow nasal cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: median percent change in PRP over 5 minute measurement period

Secondary outcomes (5)

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.
Measured: median PRP over a 5 minute period
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.
Measured: median phase angle over a 5 minute period
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.
Measured: median PRP over a 5 minute period
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.
Measured: medain percent change in PRP over a 5 minute period
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.
Measured: median of the maximum percent change in PRP over a 5 minute period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jul 2016

First posted8 Jun 2016 (estimated)
Study startSep 2014
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (26)Papers the sponsor has linked to this study.
Other trials for High Flow Nasal CannulaStudies of the same condition, open and under way.
More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02793674
Sponsor's protocol ID: CHLA-14-00239
Acronym: HFNCandEOB
Status last verified: Oct 2024
First submitted: 3 Jun 2016
Last updated: 30 Oct 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

Lee JH, Rehder KJ, Williford L, Cheifetz IM, Turner DA. Use of high flow nasal cannula in critically ill infants, children, and adults: a critical review of the literature. Intensive Care Med. 2013 Feb;39(2):247-57. doi: 10.1007/s00134-012-2743-5. Epub 2012 Nov 10.
PubMed 23143331
McKiernan C, Chua LC, Visintainer PF, Allen H. High flow nasal cannulae therapy in infants with bronchiolitis. J Pediatr. 2010 Apr;156(4):634-8. doi: 10.1016/j.jpeds.2009.10.039. Epub 2009 Dec 29.
PubMed 20036376
Schibler A, Pham TM, Dunster KR, Foster K, Barlow A, Gibbons K, Hough JL. Reduced intubation rates for infants after introduction of high-flow nasal prong oxygen delivery. Intensive Care Med. 2011 May;37(5):847-52. doi: 10.1007/s00134-011-2177-5. Epub 2011 Mar 3.
PubMed 21369809
Wing R, James C, Maranda LS, Armsby CC. Use of high-flow nasal cannula support in the emergency department reduces the need for intubation in pediatric acute respiratory insufficiency. Pediatr Emerg Care. 2012 Nov;28(11):1117-23. doi: 10.1097/PEC.0b013e31827122a9.
PubMed 23114231
Frizzola M, Miller TL, Rodriguez ME, Zhu Y, Rojas J, Hesek A, Stump A, Shaffer TH, Dysart K. High-flow nasal cannula: impact on oxygenation and ventilation in an acute lung injury model. Pediatr Pulmonol. 2011 Jan;46(1):67-74. doi: 10.1002/ppul.21326. Epub 2010 Nov 23.
PubMed 21171186
Lavizzari A, Veneroni C, Colnaghi M, Ciuffini F, Zannin E, Fumagalli M, Mosca F, Dellaca RL. Respiratory mechanics during NCPAP and HHHFNC at equal distending pressures. Arch Dis Child Fetal Neonatal Ed. 2014 Jul;99(4):F315-20. doi: 10.1136/archdischild-2013-305855. Epub 2014 Apr 30.
PubMed 24786469
Bellani G, Pesenti A. Assessing effort and work of breathing. Curr Opin Crit Care. 2014 Jun;20(3):352-8. doi: 10.1097/MCC.0000000000000089.
PubMed 24722059
Bekhof J, Reimink R, Brand PL. Systematic review: insufficient validation of clinical scores for the assessment of acute dyspnoea in wheezing children. Paediatr Respir Rev. 2014 Mar;15(1):98-112. doi: 10.1016/j.prrv.2013.08.004. Epub 2013 Oct 11.
PubMed 24120749
Klein M, Reynolds LG. Relief of sleep-related oropharyngeal airway obstruction by continuous insufflation of the pharynx. Lancet. 1986 Apr 26;1(8487):935-9. doi: 10.1016/s0140-6736(86)91043-3.
PubMed 2871240
Collett PW, Perry C, Engel LA. Pressure-time product, flow, and oxygen cost of resistive breathing in humans. J Appl Physiol (1985). 1985 Apr;58(4):1263-72. doi: 10.1152/jappl.1985.58.4.1263.
PubMed 3988680
KRIEGER I, WHITTEN CF. WORK OF RESPIRATION IN BRONCHIOLITIS. Am J Dis Child. 1964 Apr;107:386-92. doi: 10.1001/archpedi.1964.02080060388010. No abstract available.
PubMed 14109498
Stokes GM, Milner AD, Groggins RC. Work of breathing, intra-thoracic pressure and clinical findings in a group of babies with bronchiolitis. Acta Paediatr Scand. 1981 Sep;70(5):689-94. doi: 10.1111/j.1651-2227.1981.tb05769.x.
PubMed 7324919
Allen JL, Wolfson MR, McDowell K, Shaffer TH. Thoracoabdominal asynchrony in infants with airflow obstruction. Am Rev Respir Dis. 1990 Feb;141(2):337-42. doi: 10.1164/ajrccm/141.2.337.
PubMed 2137313
Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.
PubMed 24612137
Milesi C, Baleine J, Matecki S, Durand S, Combes C, Novais AR, Cambonie G. Is treatment with a high flow nasal cannula effective in acute viral bronchiolitis? A physiologic study. Intensive Care Med. 2013 Jun;39(6):1088-94. doi: 10.1007/s00134-013-2879-y. Epub 2013 Mar 14.
PubMed 23494016

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children High-altitude Pulmonary Edema
High-altitude Pulmonary Edema
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Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Recruiting
Role of HFNC During FOB in Patients With Respiratory Failure
Respiratory Failure, Respiratory Failure With Hypercapnia
RecruitingObservational study
Brain-lung Interaction During Acute Respiratory Failure
Acute Respiratory Failure
Not yet recruiting
nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDS
Respiratory Distress Syndrome, Premature Birth

All High Flow Nasal Cannula trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High-Flow Nasal Cannula Flow Titration and Effort of Breathing in the Pediatric Intensive Care Unit
ClinicalTrials.gov ID: NCT02793674
Acronym / sponsor ID: HFNCandEOB / CHLA-14-00239
Conditions: High Flow Nasal Cannula
Keywords: effort of breathing, high flow nasal cannula, respiratory distress
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Children's Hospital Los AngelesUniversity, hospital or other
Study start: Sep 2014
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 8 Jun 2016 (estimated)
Results: Posted 2 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fisher & Paykel high flow nasal cannula	Other	Device: Fisher & Paykel high flow nasal cannulaAll 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.
Vapotherm high flow nasal cannula	Other	Device: Vapotherm high flow nasal cannulaAll 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.

Who may qualify

Ages: Up to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fisher & Paykel high flow nasal cannulaMeasurements 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.	Device	Fisher & Paykel high flow nasal cannula
Vapotherm high flow nasal cannulaMeasurements 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.	Device	Vapotherm high flow nasal cannula

Primary outcome

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.

5 secondary outcomes

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
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
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
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
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

Results and safety

Results posted to the registry on 2 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fisher & Paykel (FP) HFNC	9	9
Vapotherm (VT) HFNC	12	12

Primary outcome: 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. Median (Inter-Quartile Range). Unit: percent change in PRP

Measure	Percent Change in Pressure-Rate Product n = 21
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)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 22 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fisher & Paykel (FP) High Flow Nasal Cannula	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Vapotherm (VT) High Flow Nasal Cannula	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23143331Lee JH, Rehder KJ, Williford L, Cheifetz IM, Turner DA. Use of high flow nasal cannula in critically ill infants, children, and adults: a critical review of the literature. Intensive Care Med. 2013 Feb;39(2):247-57. doi: 10.1007/s00134-012-2743-5. Epub 2012 Nov 10.
Background: PubMed 20036376McKiernan C, Chua LC, Visintainer PF, Allen H. High flow nasal cannulae therapy in infants with bronchiolitis. J Pediatr. 2010 Apr;156(4):634-8. doi: 10.1016/j.jpeds.2009.10.039. Epub 2009 Dec 29.
Background: PubMed 21369809Schibler A, Pham TM, Dunster KR, Foster K, Barlow A, Gibbons K, Hough JL. Reduced intubation rates for infants after introduction of high-flow nasal prong oxygen delivery. Intensive Care Med. 2011 May;37(5):847-52. doi: 10.1007/s00134-011-2177-5. Epub 2011 Mar 3.
Background: PubMed 23114231Wing R, James C, Maranda LS, Armsby CC. Use of high-flow nasal cannula support in the emergency department reduces the need for intubation in pediatric acute respiratory insufficiency. Pediatr Emerg Care. 2012 Nov;28(11):1117-23. doi: 10.1097/PEC.0b013e31827122a9.
Background: PubMed 21171186Frizzola M, Miller TL, Rodriguez ME, Zhu Y, Rojas J, Hesek A, Stump A, Shaffer TH, Dysart K. High-flow nasal cannula: impact on oxygenation and ventilation in an acute lung injury model. Pediatr Pulmonol. 2011 Jan;46(1):67-74. doi: 10.1002/ppul.21326. Epub 2010 Nov 23.
Background: PubMed 24786469Lavizzari A, Veneroni C, Colnaghi M, Ciuffini F, Zannin E, Fumagalli M, Mosca F, Dellaca RL. Respiratory mechanics during NCPAP and HHHFNC at equal distending pressures. Arch Dis Child Fetal Neonatal Ed. 2014 Jul;99(4):F315-20. doi: 10.1136/archdischild-2013-305855. Epub 2014 Apr 30.
Background: PubMed 24722059Bellani G, Pesenti A. Assessing effort and work of breathing. Curr Opin Crit Care. 2014 Jun;20(3):352-8. doi: 10.1097/MCC.0000000000000089.
Background: PubMed 24120749Bekhof J, Reimink R, Brand PL. Systematic review: insufficient validation of clinical scores for the assessment of acute dyspnoea in wheezing children. Paediatr Respir Rev. 2014 Mar;15(1):98-112. doi: 10.1016/j.prrv.2013.08.004. Epub 2013 Oct 11.
Background: PubMed 2871240Klein M, Reynolds LG. Relief of sleep-related oropharyngeal airway obstruction by continuous insufflation of the pharynx. Lancet. 1986 Apr 26;1(8487):935-9. doi: 10.1016/s0140-6736(86)91043-3.
Background: PubMed 3988680Collett PW, Perry C, Engel LA. Pressure-time product, flow, and oxygen cost of resistive breathing in humans. J Appl Physiol (1985). 1985 Apr;58(4):1263-72. doi: 10.1152/jappl.1985.58.4.1263.
Background: PubMed 14109498KRIEGER I, WHITTEN CF. WORK OF RESPIRATION IN BRONCHIOLITIS. Am J Dis Child. 1964 Apr;107:386-92. doi: 10.1001/archpedi.1964.02080060388010. No abstract available.
Background: PubMed 7324919Stokes GM, Milner AD, Groggins RC. Work of breathing, intra-thoracic pressure and clinical findings in a group of babies with bronchiolitis. Acta Paediatr Scand. 1981 Sep;70(5):689-94. doi: 10.1111/j.1651-2227.1981.tb05769.x.
Study Results: The Relationship between High Flow Nasal Cannula Flow Rate and Effort of Breathing in ChildrenLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02793674, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.