Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2025-12-17 @ 2:27 AM
Study NCT ID:
NCT04582838
Status:
None
Last Update Posted:
2021-08-03 00:00:00
First Post:
2020-10-04 00:00:00
Brief Title:
Photoplethysmographic Scaling of Dyspnoea
Sponsor:
Institutul de Urgenţă pentru Boli Cardiovasculare ProfDr CC Iliescu
Organization:
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Study Overview
Official Title:
Photoplethysmographic Signal Analysis as a Proxy for Excessive Effort and Impending Respiratory Failure
Status:
None
Status Verified Date:
2021-08
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:
DYSPO
Brief Summary:
Initiating invasive mechanical ventilation is a vital and delay-critical decision. Precise and timely prediction of impending respiratory failure would be highly consequential. Subjective evaluation of respiratory loading conditions is inconsistent, imprecise and may result in erroneous management. Photoplethysmographic (POP) waveform analysis provides a non-invasive, readily available tool to estimate breathing effort in a semiquantitative fashion.
It is the aim of this study to examine:
1. if the degree of dyspnoea, when clinically assessed by means of the respiratory rate and SpO2 values, correlates with the SpO2 wave variations (ΔPOP) in ICU spontaneously breathing COVID-19 and non-COVID-19 patients.
2. if a ΔPOP threshold could be identified to adequately predict further need of orotracheal intubation and invasive mechanical ventilation.
This study consists of three main steps:
1. Clinical evaluation of dyspnoea based on:
1.1. Respiratory rate
1.2. Oxygen saturation (SpO2)
2. Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after offline POP analysis .
3. Within a time frame of 10 days from when the first two steps are met, monitor for need of invasive ventilatory support.
It is the aim of this study to examine:
1. if the degree of dyspnoea, when clinically assessed by means of the respiratory rate and SpO2 values, correlates with the SpO2 wave variations (ΔPOP) in ICU spontaneously breathing COVID-19 and non-COVID-19 patients.
2. if a ΔPOP threshold could be identified to adequately predict further need of orotracheal intubation and invasive mechanical ventilation.
This study consists of three main steps:
1. Clinical evaluation of dyspnoea based on:
1.1. Respiratory rate
1.2. Oxygen saturation (SpO2)
2. Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after offline POP analysis .
3. Within a time frame of 10 days from when the first two steps are met, monitor for need of invasive ventilatory support.
Detailed Description:
Initiating invasive mechanical ventilation is a vital and delay-critical decision Precise and timely prediction of impending respiratory failure would be highly consequential Subjective evaluation of respiratory loading conditions is inconsistent imprecise and may result in erroneous management Photoplethysmographic POP waveform analysis provides a non-invasive readily available tool to estimate breathing effort in a semiquantitative fashion
It is the aim of this study to examine
1 if the degree of dyspnoea when clinically assessed by means of the respiratory rate and SpO2 values correlates with the SpO2 wave variations ΔPOP in ICU spontaneously breathing COVID-19 and non-COVID-19 patients
2 if a ΔPOP threshold could be identified to adequately predict further need of orotracheal intubation and invasive mechanical ventilation
This study consists of three main steps
1 Clinical evaluation of dyspnoea based on
11 Respiratory rate
12 Oxygen saturation SpO2
2 Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after offline POP analysis
3 Within a time frame of 10 days from when the first two steps are met monitor for need of invasive ventilatory support
It is the aim of this study to examine
1 if the degree of dyspnoea when clinically assessed by means of the respiratory rate and SpO2 values correlates with the SpO2 wave variations ΔPOP in ICU spontaneously breathing COVID-19 and non-COVID-19 patients
2 if a ΔPOP threshold could be identified to adequately predict further need of orotracheal intubation and invasive mechanical ventilation
This study consists of three main steps
1 Clinical evaluation of dyspnoea based on
11 Respiratory rate
12 Oxygen saturation SpO2
2 Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after offline POP analysis
3 Within a time frame of 10 days from when the first two steps are met monitor for need of invasive ventilatory support
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Dyspnoea - SpO2 curve study | OTHER | CC Iliescu Institute | None |