Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-01 @ 3:43 PM
Study NCT ID:
NCT02899351
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2016-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants
Status:
COMPLETED
Status Verified Date:
2021-10
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:
In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation).
It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected.
The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.
It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected.
The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: