Photoplethysmographic Scaling of Dyspnoea

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu60 enrolled

Overview

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: 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Failure

Interventions

Pulse oximeterDIAGNOSTIC_TEST

In both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2). Also, SpO2 curve can be recorded for off-line analysis.

ECGDIAGNOSTIC_TEST

ECG signal is used to monitor respiratory rate (RR).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent from patient or next-of-kin according to local administrative decision * Spontaneous breathing, including during prone position * Sinus rhythm * Minimum standards for ICU monitoring: ECG, blood pressure (invasive or non-invasive), respiratory rate (by ECG signal), SpO2 and temperature Exclusion Criteria: * Suspected pregnancy * Weight \> 120 Kg or \< 60 kg * Emergency or urgency * Intubated ( and mechanically ventilated) patient * Non- sinus rhythm * Left ventricular ejection fraction (LVEF) ≤ 30% * Right ventricular (RV) dysfunction ( RVEF ≤ 30% at transthoracic echocardiography (TTE)) * Significant pulmonary hypertension (PHT) (TTE: mean pulmonary arterial pressure (mPAP) ≥ 35 mm.Hg)

Locations (2)

Clinical Emergency Hospital Bucharest

Bucharest, Romania

Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"

Bucharest, Romania

Outcomes

Primary Outcomes

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

Time frame: Day 10

Secondary Outcomes

Respiratory rate

Patient's respiratory rate during non-invasive respiratory support as derived from an ECG signal

Time frame: 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

Time frame: Day 0

ΔPOP

Photoplethysmographic variation index following offline computation of the SpO2 curve stored at day 0 according to a proprietary algorithm

Time frame: day 0

Data from ClinicalTrials.gov

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