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Completed

NCT Number: NCT02387632

Airway Pressure During Humidified High Flow Nasal Cannula Therapy in Children

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.

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Key information

Age range

2 week–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2015
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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