Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03976986
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2019-05-31
Brief Title:
Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing
Sponsor:
Hospital Son Espases
Organization:
Hospital Son Espases
Study Overview
Official Title:
Assessment of Portable Oxygen Concentrators in Infants Undergoing Hypoxic Challenge Testing A Randomized Crossover Study
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypoxic Challenge Testing HCT is the recommended method for inflight hypoxia risk assessment Onboard oxygen administration remains controversial The Federal Aviation Administration approved portable oxygen concentrators POCs for onboard oxygen supply but there is lack of evidence about the use especially in children The aim of our study is to establish the effectiveness and safety of POCs in infants undergoing HCT
Detailed Description:
According to a forecast by International Air Transport Association the number of people travelling on commercial aircrafts is predicted to rise up to 82 billion passengers in 2037 Therefore evidence-based flight recommendations will gain importance in the future especially for patients suffering from chronic diseases Hypoxic Challenge Testing HCT is the recommended method for inflight hypoxia risk assessment where nitrogen is introduced in a plethysmograph reducing FiO2 fraction of inspired oxygen to 015 Oxygen supply is recommended if PaO2 partial pressure of oxygen in arterial blood drops 50-55 mmHg in adults or SatO2 oxygen saturation 85 in infants where non-invasive pulse oximetry is the recommended method for hypoxia assessment Onboard oxygen administration remains controversial The effectiveness of pulsed-dosed systems remains unclear in small patients due to shallow breathing patterns The aim of our study is to establish the effectiveness and safety of POCs in infants undergoing HCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None