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Airway Pressure During Humidified High Flow Nasal Cannula Therapy in Children

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2015 by Karen Choong, McMaster University
Sponsor:
Information provided by (Responsible Party):
Karen Choong, McMaster University
ClinicalTrials.gov Identifier:
NCT02387632
First received: March 8, 2015
Last updated: March 14, 2016
Last verified: November 2015
  Purpose
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.

Condition
Bronchiolitis Pneumonia Bronchial Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Airway Pressure During Humidified High Flow Nasal Cannula Therapy in Children

Further study details as provided by Karen Choong, McMaster University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: June 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Continuous or intermittent NG or OG tube suction is required.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02387632

Contacts
Contact: Karen Choong, FRCP(C) 905-525-9140 ext 75617 choongk@mcmaster.ca
Contact: Hamood Alshueili, MD 905-521-2610 han28931@gmail.com

Locations
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Karen Choong, MB, BCh, MSc    905-5212100 ext 75617    choongk@mcmaster.ca   
Principal Investigator: Hamood Al Shuieli, MD         
Principal Investigator: Juliana Giraldo Salazar, MD         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Karen Choong, FRCP(C) McMaster University
  More Information

Responsible Party: Karen Choong, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT02387632     History of Changes
Other Study ID Numbers: 15-079
Study First Received: March 8, 2015
Last Updated: March 14, 2016

Additional relevant MeSH terms:
Pneumonia
Bronchiolitis
Asthma
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2017