Respiratory FailureDYSPONCT04582838
Photoplethysmographic Scaling of Dyspnoea
An observational study of Respiratory Failure, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 2 sites in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Pulse oximeter and ECG
- How many people
- 60 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Oct 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spontaneously breathing ICU (COVID and non-COVID-19) adult patients with sinus rhythm, under any form of non-invasive respiratory support.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Clinical Emergency Hospital Bucharest
Bucharest, 014461
Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
Bucharest, 030303
About this study
Official title: 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.
Read the 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: 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.
- Conditions
- Respiratory Failure
- Being tested
- Pulse oximeter, ECG
- Keywords
- breathing, effort, plethysmography, pulse oximetry, dyspnoea, mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDiagnostic test
In both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2).
Also, SpO2 curve can be recorded for off-line analysis.
ECGDiagnostic test
ECG signal is used to monitor respiratory rate (RR).
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing ICU non-COVID | Spontaneously breathing non-COVID-19 critically ill patients with sinus rhythm.
Inclusion and exclusion criterion are listed elsewhere. Receives: Diagnostic Test: Pulse oximeter; Diagnostic Test: ECG | |
| Spontaneous breathing ICU COVID | Spontaneously breathing COVID-19 critically ill patients with sinus rhythm.
Inclusion and exclusion criterion are listed elsewhere. Receives: Diagnostic Test: Pulse oximeter; Diagnostic Test: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 10
Secondary outcomes (3)
Respiratory rate
Patient's respiratory rate during non-invasive respiratory support as derived from an ECG signal
Measured: 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
Measured: Day 0
ΔPOP
Photoplethysmographic variation index following offline computation of the SpO2 curve stored at day 0 according to a proprietary algorithm
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Oct 2020
- Primary completion30 May 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Investigators
- Serban I Bubenek Turconi, Professor, Study chair, Emergency Institute for Cardiovascular Diseases Prof Dr CC Iliescu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582838
- Sponsor's protocol ID
- 18751
- Other IDs
- Dyspnoea - SpO2 curve study
- Acronym
- DYSPO
- Status last verified
- Aug 2021
- First submitted
- 4 Oct 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28126420Perel 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.
PubMed 25405690Khandoker 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.
PubMed 24111249Addison 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.
PubMed 26377021
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoplethysmographic Signal Analysis as a Proxy for Excessive Effort and Impending Respiratory Failure
- ClinicalTrials.gov ID
- NCT04582838
- Acronym / sponsor ID
- DYSPO / 18751
- Conditions
- Respiratory Failure
- Keywords
- breathing, effort, plethysmography, pulse oximetry, dyspnoea, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing ICU non-COVID | – | Diagnostic Test: Pulse oximeter, Diagnostic Test: ECGSpontaneously breathing non-COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere. |
| Spontaneous breathing ICU COVID | – | Diagnostic Test: Pulse oximeter, Diagnostic Test: ECGSpontaneously breathing COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spontaneously breathing ICU (COVID and non-COVID-19) adult patients with sinus rhythm, under any form of non-invasive respiratory support.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Suspected pregnancy
- Weight > 120 Kg or < 60 kg
- Emergency or urgency
- Intubated ( and mechanically ventilated) patient
- Non- sinus rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeterIn both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2). Also, SpO2 curve can be recorded for off-line analysis. | Diagnostic test | Spontaneous breathing ICU COVID, Spontaneous breathing ICU non-COVID |
| ECGECG signal is used to monitor respiratory rate (RR). | Diagnostic test | Spontaneous breathing ICU COVID, Spontaneous breathing ICU non-COVID |
Primary outcome
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
3 secondary outcomes
Respiratory rate
Time frame: Day 0
SpO2 under non-invasive respiratory support
Time frame: Day 0
ΔPOP
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 28126420Addison 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.
- Background: PubMed 25405690Perel 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.
- Background: PubMed 24111249Khandoker 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.
- Background: PubMed 26377021Addison 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.
- Individual participant dataSharing planned: Undecided
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
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Mechanical Ventilator Adjustments and Patient Dyspnea
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Clinical Genetics Branch Eligibility Screening Survey
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serban I Bubenek Turconi, Professor study chair
Emergency Institute for Cardiovascular Diseases Prof Dr CC Iliescu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of failure of spontaneous breathing (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582838, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.