Photoplethysmographic Scaling of Dyspnoea

NCT04582838 | Completed DMC

• 2 other identifiers: 18751Dyspnoea - SpO2 curve study
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Failure

Keywords

breathing; effort; plethysmography; pulse oximetry; dyspnoea; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Respiratory rate

  Day 0

• SpO2 under non-invasive respiratory support

  Day 0

• ΔPOP

  day 0

Study Arms (2)

Spontaneous breathing ICU non-COVID

Spontaneously breathing non-COVID-19 critically ill patients with sinus rhythm. Inclusion and exclusion criterion are listed elsewhere.

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.

Diagnostic Test: Pulse oximeter; Diagnostic Test: ECG

Interventions

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.

Spontaneous breathing ICU COVID; Spontaneous breathing ICU non-COVID

ECG DIAGNOSTIC_TEST

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

Spontaneous breathing ICU COVID; Spontaneous breathing ICU non-COVID

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu: lead

Study Sites (2)

Clinical Emergency Hospital Bucharest

Bucharest, 014461, Romania

Location

Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"

Bucharest, 030303, Romania

Location

Related 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.

  PMID: 28126420 BACKGROUND

• 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.

  PMID: 25405690 BACKGROUND

• 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.

  PMID: 24111249 BACKGROUND

• 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.

  PMID: 26377021 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration; Dyspnea

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Serban I Bubenek Turconi, Professor

  Emergency Institute for Cardiovascular Diseases Prof Dr CC Iliescu

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anaesthesia and ICM

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 12, 2020
• Study Start: October 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: July 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

RO (2)