Photoplethysmographic Scaling of Dyspnoea (DYSPO)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Diagnostic test: Pulse oximeter; Diagnostic test: ECG

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 014461
    • Clinical Emergency Hospital Bucharest
  • Bucharest, Romania, 030303
    • Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Spontaneously breathing ICU (COVID and non-COVID-19) adult patients with sinus rhythm, under any form of non-invasive respiratory support.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spontaneous breathing ICU non-COVID; Spontaneously breathing non-COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere.	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).
Spontaneous breathing ICU COVID; Spontaneously breathing COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
• Investigators: Study Chair: Serban I Bubenek Turconi, Professor, Emergency Institute for Cardiovascular Diseases Prof Dr CC Iliescu

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 4, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: mechanical ventilation; breathing; pulse oximetry; effort; dyspnoea; plethysmography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 18751; Dyspnoea - SpO2 curve study (Other Identifier: CC Iliescu Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No