Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Dyspnoea - SpO2 curve study | Other Identifier | CC Iliescu Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Timely prediction of impending respiratory failure is vital, yet relies on subjective clinical assessment of the patient's respiratory status. Pulse oximetry plethysmographic signal analysis is indicative of the effort to breathe and may provide an objective measurement of respiratory loading.
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:
This study consists of three main steps:
Clinical evaluation of dyspnoea based on:
1.1. Respiratory rate
1.2. Oxygen saturation (SpO2)
Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after offline POP analysis .
Within a time frame of 10 days from when the first two steps are met, monitor for need of invasive ventilatory support.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous breathing ICU non-COVID | Spontaneously breathing non-COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere. |
| |
| Spontaneous breathing ICU COVID | Spontaneously breathing COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximeter | Diagnostic Test | In both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2). Also, SpO2 curve can be recorded for off-line analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of failure of spontaneous breathing | Number of patients who fail spontaneous breathing (SB). Failure of SB is defined as death or need of invasive mechanical ventilation whereas SB includes any form of non-invasive ventilatory support | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | Patient's respiratory rate during non-invasive respiratory support as derived from an ECG signal | Day 0 |
| SpO2 under non-invasive respiratory support | Peripheral oxygen saturation (SpO2) as measured with a pulse oximeter during any form of non-invasive ventilatory support |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Spontaneously breathing ICU (COVID and non-COVID-19) adult patients with sinus rhythm, under any form of non-invasive respiratory support.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Serban I Bubenek Turconi, Professor | Emergency Institute for Cardiovascular Diseases Prof Dr CC Iliescu | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Emergency Hospital Bucharest | Bucharest | 014461 | Romania | |||
| Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28126420 | Background | Addison PS. Respiratory effort from the photoplethysmogram. Med Eng Phys. 2017 Mar;41:9-18. doi: 10.1016/j.medengphy.2016.12.010. Epub 2017 Jan 23. | |
| 25405690 | Background | Perel A. Excessive variations in the plethysmographic waveform during spontaneous ventilation: an important sign of upper airway obstruction. Anesth Analg. 2014 Dec;119(6):1288-92. doi: 10.1213/ANE.0000000000000378. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D053120 | Respiratory Aspiration |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| ECG | Diagnostic Test | ECG signal is used to monitor respiratory rate (RR). |
|
| Day 0 |
| ΔPOP | Photoplethysmographic variation index following offline computation of the SpO2 curve stored at day 0 according to a proprietary algorithm | day 0 |
| Bucharest |
| 030303 |
| Romania |
| 24111249 | Background | Khandoker AH, Karmakar CK, Penzel T, Glos M, Schoebel C, Palaniswami M. Estimating relative respiratory effort from features of Photo-Plethysmography signal. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6575-8. doi: 10.1109/EMBC.2013.6611062. |
| 26377021 | Background | Addison PS. Respiratory modulations in the photoplethysmogram (DPOP) as a measure of respiratory effort. J Clin Monit Comput. 2016 Oct;30(5):595-602. doi: 10.1007/s10877-015-9763-y. Epub 2015 Sep 16. |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D004568 | Electrodiagnosis |