Photoplethysmographic Signal Analysis as a Proxy for Excessive Effort and Impending Respiratory Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Rate of failure of spontaneous breathing
Study Overview
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:
- 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- Respiratory rate(Day 0)
- SpO2 under non-invasive respiratory support(Day 0)
- ΔPOP(day 0)
Investigators
Balan Ion Cosmin
Consultant in Anaesthesia and ICM
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu