NCT02387632

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 6, 2019

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

March 8, 2015

Last Update Submit

March 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Airway pressure measurement

    oesophageal pressure will be measured as a surrogate of airway pressure using Nasogastric tube liquid filled technique.

    will be measured at start of HHFNC therapy and with titration of flow rate.

Secondary Outcomes (1)

  • predictors of positive airway pressure delivery.

    will be measured simultaneously with airway pressure

Eligibility Criteria

Age2 Weeks - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Continuous or intermittent NG or OG tube suction is required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

BronchiolitisPneumoniaAsthma

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Karen Choong, FRCP(C)

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2015

First Posted

March 13, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 6, 2019

Record last verified: 2015-11

Locations