BronchiolitisNCT02387632
Airway Pressure During Humidified High Flow Nasal Cannula Therapy in Children
An observational study of Bronchiolitis and Pneumonia, run by McMaster University at 1 site in Canada.
Trial summary
Humidified High Flow Nasal Cannula (HHFNC) is a new modality of respiratory support for children with respiratory failure. Despite its extensive use in pediatric and adult population, the exact mechanism of work of HHFNC is not fully explained.The objective of the investigators' research project is to determine the… Read more about this study
- Who is it for?
- Ages 2 weeks to 18 years
- Conditions the study is for
- Bronchiolitis, Pneumonia, Bronchial Asthma
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under 18 years, admitted to PCCU, who require respiratory support using HHFNC, as determined by the caring physician; and informed consent of substitute decision maker will be included in the study.
Who may be able to join
- Aged less than 18 years, admitted to PCCU with acute respiratory distress.
- HHFNC respiratory support prescribed by the caring physician.
- Requirement for a size 10 French or smaller nasogastric (NG) or orogastric (OG) tube, as prescribed by the caring physician.
- Informed consent, and/- or assent where appropriate.
Who cannot join
- Continuous or intermittent NG or OG tube suction is required.
Trial locations and contacts
1 site in 1 country.
About this study
Humidified High Flow Nasal Cannula (HHFNC) is a new modality of respiratory support for children with respiratory failure. Despite its extensive use in pediatric and adult population, the exact mechanism of work of HHFNC is not fully explained.The objective of the investigators' research project is to determine the relationship between the amount of airway pressure that can be delivered at specific flow levels of HHFNC. This information will allow the investigators to use HHFNC in a much more informed and safe manner.
Read the detailed description
Background: Respiratory failure is one of the most common reasons for admission to the Pediatric Critical Care Unit (PCCU). 17% of children admitted to a PCCU require some form of invasive or non-invasive mechanical respiratory support. HHFNC therapy was first introduced in early 2000 and hence is a relatively new mode of respiratory support. One of the proposed mechanisms of action of HHFNC is by providing airway positive pressure hence considered as non-invasive mode of ventilation in pediatrics. However, the actual amount of positive airway pressure that HHFNC provides at increasing flow rates has not been well studied in children.
Objectives: The investigators' objectives are to measure the positive airway pressure delivered with increasing HHFNC flow rates in children, and to evaluate the variables that may influence the delivery of positive airway pressure during HHFNC.
Methods \& Design: This is an observational cohort study which will be conducted at McMaster children's hospital, pediatric critical care unit (PCCU). Children under 18 years of age, admitted to PCCU, who require respiratory support by HHFNC, as determined by the caring physician; and informed consent and or assent of substitute decision maker. Those children must have NG tube of size 10 French or smaller inserted at time of HHFNC application. Patients who are on intermittent NGT suction will be excluded. Airway pressure will be measured indirectly using esophageal pressure liquid filled method.
Data Analysis Baseline demographics will be summarized using counts (%) for categorical variables, and mean (standard deviation) or median and interquartile range (IQR) as appropriate for continuous variables. Estimates of the pressure will be reported as mean (95% confidence interval [CI]). Relationship of pressure to delivered flow will be analysed using analysis of variance. Regression methods will be used to determine if the following factors delivered flow per weight of patient, patient size, disease severity, work of breathing and nasal cannula: nares diameter ratio are associated with air pressure
- Conditions
- Bronchiolitis, Pneumonia, Bronchial Asthma
- Medical subject headings
- Bronchiolitis, Pneumonia, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway pressure measurement
oesophageal pressure will be measured as a surrogate of airway pressure using Nasogastric tube liquid filled technique.
Measured: will be measured at start of HHFNC therapy and with titration of flow rate.
Secondary outcomes (1)
predictors of positive airway pressure delivery.
The secondary outcomes of this study are predictors that may influence the delivery of positive airway pressures during HHFNC, such as the delivered flow per weight of patient, disease severity, work of breathing and nasal cannula: nares diameter ratio.
Measured: will be measured simultaneously with airway pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Choong, McMaster University
- Investigators
- Karen Choong, FRCP(C), Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387632
- Sponsor's protocol ID
- 15-079
- Status last verified
- Nov 2015
- First submitted
- 8 Mar 2015
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Pressure During Humidified High Flow Nasal Cannula Therapy in Children
- ClinicalTrials.gov ID
- NCT02387632
- Acronym / sponsor ID
- 15-079
- Conditions
- Bronchiolitis, Pneumonia, Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Humidified High Flow Nasal Cannula (HHFNC) is a new modality of respiratory support for children with respiratory failure. Despite its extensive use in pediatric and adult population, the exact mechanism of work of HHFNC is not fully explained.The objective of the investigators' research project is to determine the relationship between the amount of airway pressure that can be delivered at specific flow levels of HHFNC. This information will allow the investigators to use HHFNC in a much more informed and safe manner.
Detailed description
Background: Respiratory failure is one of the most common reasons for admission to the Pediatric Critical Care Unit (PCCU). 17% of children admitted to a PCCU require some form of invasive or non-invasive mechanical respiratory support. HHFNC therapy was first introduced in early 2000 and hence is a relatively new mode of respiratory support. One of the proposed mechanisms of action of HHFNC is by providing airway positive pressure hence considered as non-invasive mode of ventilation in pediatrics. However, the actual amount of positive airway pressure that HHFNC provides at increasing flow rates has not been well studied in children.
Objectives: The investigators' objectives are to measure the positive airway pressure delivered with increasing HHFNC flow rates in children, and to evaluate the variables that may influence the delivery of positive airway pressure during HHFNC.
Methods \& Design: This is an observational cohort study which will be conducted at McMaster children's hospital, pediatric critical care unit (PCCU). Children under 18 years of age, admitted to PCCU, who require respiratory support by HHFNC, as determined by the caring physician; and informed consent and or assent of substitute decision maker. Those children must have NG tube of size 10 French or smaller inserted at time of HHFNC application. Patients who are on intermittent NGT suction will be excluded. Airway pressure will be measured indirectly using esophageal pressure liquid filled method.
Data Analysis Baseline demographics will be summarized using counts (%) for categorical variables, and mean (standard deviation) or median and interquartile range (IQR) as appropriate for continuous variables. Estimates of the pressure will be reported as mean (95% confidence interval [CI]). Relationship of pressure to delivered flow will be analysed using analysis of variance. Regression methods will be used to determine if the following factors delivered flow per weight of patient, patient size, disease severity, work of breathing and nasal cannula: nares diameter ratio are associated with air pressure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 18 years, admitted to PCCU, who require respiratory support using HHFNC, as determined by the caring physician; and informed consent of substitute decision maker will be included in the study.
Key inclusion criteria (4 listed)
- Aged less than 18 years, admitted to PCCU with acute respiratory distress.
- HHFNC respiratory support prescribed by the caring physician.
- Requirement for a size 10 French or smaller nasogastric (NG) or orogastric (OG) tube, as prescribed by the caring physician.
- Informed consent, and/- or assent where appropriate.
Key exclusion criteria (1 listed)
- Continuous or intermittent NG or OG tube suction is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Airway pressure measurement
Time frame: will be measured at start of HHFNC therapy and with titration of flow rate.
oesophageal pressure will be measured as a surrogate of airway pressure using Nasogastric tube liquid filled technique.
1 secondary outcome
predictors of positive airway pressure delivery.
Time frame: will be measured simultaneously with airway pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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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.
Karen Choong, FRCP(C) principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis and Pneumonia, run by McMaster University at 1 site in Canada.
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 4 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 6 Mar 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Airway pressure measurement (time frame: will be measured at start of HHFNC therapy and with titration of flow rate.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2019.