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Completed

NCT Number: NCT04582838

Photoplethysmographic Scaling of Dyspnoea

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Emergency Hospital Bucharest, Bucharest, Romania

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About this study

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:

  • 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.
  • 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:

  • Clinical evaluation of dyspnoea based on:

1.1. Respiratory rate

1.2. Oxygen saturation (SpO2)

  • Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after offline POP analysis .
  • Within a time frame of 10 days from when the first two steps are met, monitor for need of invasive ventilatory support.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pulse oximeter

Diagnostic Test

In both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2).

Also, SpO2 curve can be recorded for off-line analysis.

ECG

Diagnostic Test

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

Primary outcomes

  1. Rate of failure of spontaneous breathing

    Time frame: 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 outcomes

  1. Respiratory rate

    Time frame: Day 0

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

  2. SpO2 under non-invasive respiratory support

    Time frame: Day 0

    Peripheral oxygen saturation (SpO2) as measured with a pulse oximeter during any form of non-invasive ventilatory support

  3. ΔPOP

    Time frame: day 0

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

Sponsors and collaborators

Lead sponsor

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Other

Registry information

Official study title

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

Acronym: DYSPO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2020
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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