NCT04582838

Photoplethysmographic Scaling of Dyspnoea

Photoplethysmographic Signal Analysis as a Proxy for Excessive Effort and Impending Respiratory Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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: 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.

Conditions

• Respiratory Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pulse oximeter	In both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2). Also, SpO2 curve can be recorded for off-line analysis.
DIAGNOSTIC_TEST	ECG	ECG signal is used to monitor respiratory rate (RR).

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-05-30
• Completion: 2021-07-30
• First posted: 2020-10-12
• Last updated: 2021-08-03

Locations

2 sites across 1 country: Romania