Airway Pressure During Humidified High Flow Nasal Cannula Therapy in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02387632|
Recruitment Status : Unknown
Verified November 2015 by Karen Choong, McMaster University.
Recruitment status was: Recruiting
First Posted : March 13, 2015
Last Update Posted : March 16, 2016
|Condition or disease|
|Bronchiolitis Pneumonia Bronchial Asthma|
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 Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Airway Pressure During Humidified High Flow Nasal Cannula Therapy in Children|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
- 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.
- predictors of positive airway pressure delivery. [ Time Frame: will be measured simultaneously with airway pressure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387632
|Contact: Karen Choong, FRCP(C)||905-525-9140 ext email@example.com|
|Contact: Hamood Alshueili, MDfirstname.lastname@example.org|
|McMaster Children's Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Contact: Karen Choong, MB, BCh, MSc 905-5212100 ext 75617 email@example.com|
|Principal Investigator: Hamood Al Shuieli, MD|
|Principal Investigator: Juliana Giraldo Salazar, MD|
|Principal Investigator:||Karen Choong, FRCP(C)||McMaster University|