Clinical trial NCT04582838: Photoplethysmographic Scaling of Dyspnoea
Official title: Photoplethysmographic Signal Analysis as a Proxy for Excessive Effort and Impending Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: breathing
effort
plethysmography
pulse oximetry
dyspnoea
mechanical ventilation
Lead sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of failure of spontaneous breathing
timeFrame: Day 10
Secondary outcomes:
measure: Respiratory rate
timeFrame: Day 0
measure: SpO2 under non-invasive respiratory support
timeFrame: Day 0
measure: ΔPOP
timeFrame: day 0
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Clinical Emergency Hospital Bucharest
city: Bucharest
country: Romania
facility: Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
Study officials:
affiliation: Emergency Institute for Cardiovascular Diseases Prof Dr CC Iliescu
name: Serban I Bubenek Turconi, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.