Photoplethysmographic Scaling of Dyspnoea

Completed

• Conditions: Respiratory Failure
• Interventions: Diagnostic Test: Pulse oximeter; Diagnostic Test: ECG

• Registration Number: NCT04582838
• Lead Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Brief 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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-04
• Study First Submitted QC: 2020-10-04
• Study First Posted: 2020-10-12
• Primary Completion: 2021-05-30
• Study Completion: 2021-07-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spontaneous breathing ICU COVID	Pulse oximeter	Spontaneously breathing COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere.
Spontaneous breathing ICU non-COVID	Pulse oximeter	Spontaneously breathing non-COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere.
Spontaneous breathing ICU non-COVID	ECG	Spontaneously breathing non-COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere.
Spontaneous breathing ICU COVID	ECG	Spontaneously breathing COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere.

Primary Outcome Measures

Name	Time	Method
Rate of failure of spontaneous breathing	Day 10	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

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	Day 0	Patient's respiratory rate during non-invasive respiratory support as derived from an ECG signal
SpO2 under non-invasive respiratory support	Day 0	Peripheral oxygen saturation (SpO2) as measured with a pulse oximeter during any form of non-invasive ventilatory support
ΔPOP	day 0	Photoplethysmographic variation index following offline computation of the SpO2 curve stored at day 0 according to a proprietary algorithm

Trial Locations

Locations (2)

Clinical Emergency Hospital Bucharest; 🇷🇴 Bucharest, Romania

Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"; 🇷🇴 Bucharest, Romania