Photoplethysmographic Scaling of Dyspnoea

Respiratory Failure Clinical Trial

— DYSPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582838
• Other study ID #: 18751
• Secondary ID: Dyspnoea - SpO2
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Romania	Clinical Emergency Hospital Bucharest	Bucharest
Romania	Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Country where clinical trial is conducted

Romania, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory rate	Patient's respiratory rate during non-invasive respiratory support as derived from an ECG signal	Day 0
Secondary	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
Secondary	?POP	Photoplethysmographic variation index following offline computation of the SpO2 curve stored at day 0 according to a proprietary algorithm	day 0