Nasal High Flow Therapy in the Paediatric Home Setting

High Flow Nasal Cannula Therapy in the Paediatric Home Setting

Sponsors

Lead Sponsor: Rabin Medical Center

Collaborator: Fisher and Paykel Healthcare

Source Rabin Medical Center
Brief Summary

High flow nasal cannula (HFNC) therapy is non-invasive respiratory support designed to deliver a high flow of heated humidified air, with or without entrained oxygen, via specifically designed nasal prongs. Initially developed for preterm infants, the application of the technology is rapidly spreading to include pediatric patients with various indications, including bronchiolitis, obstructive sleep apnea (OSA), tracheomalacia, asthma, post- extubation support, and even adult hypoxemic respiratory failure.

Since it appears to be better tolerated than traditional modes of non-invasive ventilation, such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), it is increasingly used outside the intensive care setting, despite limited evidence of its safety and efficacy. In Israel, HFNC is approved for home support of children requiring non-invasive respiratory support on the recommendation of a paediatric pulmonologist or intensivist, provided that CPAP and BiPAP have been trialed and deemed not tolerated by the patient.

At Schneider Childrens' Medical Center of Israel (SCMI), a tertiary paediatric hospital, therapy is commenced during a brief inpatient stay, at a period of clinical stability. Parents are trained in the use of the device and flow rate is titrated to clinical response.

The investigators aim to describe the safety, indications, parameters of utilization, length of treatment, clinical outcomes and parental satisfaction of HFNC in the paediatric home setting.

Detailed Description

High flow nasal cannula (HFNC) therapy is non-invasive respiratory support designed to deliver a high flow of heated humidified air, with or without entrained oxygen, via specifically designed nasal prongs. Its physiological benefits include flow-dependent positive airway pressure, alveolar recruitment and washout of carbon dioxide from the upper airway. The reduction of esophageal pressure changes during respiration, compared with standard non-occlusive oxygen facemask, indicates its capacity to ease inspiratory effort.

Initially developed for preterm infants, the application of this technology is rapidly spreading to include pediatric patients with various indications, including bronchiolitis, obstructive sleep apnea (OSA), tracheomalacia, asthma, post-extubation support, and even adult hypoxemic respiratory failure.

Since it appears to be better tolerated than traditional modes of non-invasive ventilation, such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), it is increasingly used outside the intensive care setting, despite limited evidence of its safety and efficacy.

In Israel, HFNC is approved for home support of children requiring non-invasive respiratory support on the recommendation of a paediatric pulmonologist or intensivist, provided that CPAP and BiPAP have been trialed and deemed not tolerated by the patient. At Schneider Childrens' Medical Center of Israel (SCMI), a tertiary paediatric hospital, therapy is commenced during a brief inpatient stay, at a period of clinical stability. Parents are trained in the use of the device and flow rate is titrated to clinical response.

The investigators aim to describe the safety, indications, parameters of utilization, length of treatment, clinical outcomes and parental satisfaction of HFNC in the paediatric home setting.

Medical records of children aged 0-18 years who were prescribed a HFNC device at Schneider Children's between 2014-2018 for use in the home setting will be reviewed retrospectively. Demographic and clinical data will be collected. This will be supplemented by a standardized telephone questionnaire. Verbal consent will be obtained from one of the parents, and documented. As part of the telephone consent process, parents will be offered to "opt out" at the beginning of the interview.

Overall Status Recruiting
Start Date March 26, 2019
Completion Date December 2020
Primary Completion Date March 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Change in cumulative days of hospital admission 6 months before compared to 6 months after starting high flow nasal cannula treatment
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: Questionnaire

Description: Medical records of children aged 0-18 years who were prescribed a HFNC device at Schneider Children's between 2014-2018 for use in the home setting will be reviewed retrospectively. As part of the telephone consent process, parents will be offered to "opt out" at the beginning of the interview.

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

1. Any child who received HFNC

2. Previously trialed CPAP and BiPaP and deemed not tolerated by patient.

Exclusion Criteria:

N/A

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Patrick Stafler Principal Investigator Schneider Children's
Overall Contact

Last Name: Patrick Stafler

Phone: 00972547243623

Email: [email protected]

Location
Facility: Status: Contact: Schneider Children's Medical Center of Israel Patrick Stafler, MD 972547243623 [email protected]
Location Countries

Israel

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rabin Medical Center

Investigator Full Name: Patrick Stafler

Investigator Title: Senior Pulmonologist

Has Expanded Access No
Condition Browse
Acronym HFNC
Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Retrospective

Source: ClinicalTrials.gov