Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04037839 |
| Other study ID # |
Vapotherm |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 26, 2019 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
September 2021 |
| Source |
Rabin Medical Center |
| Contact |
Patrick Stafler |
| Phone |
00972547243623 |
| Email |
pstafler[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
