Persistent Dyspnea in Post COVID_19 and Pulmonary Function

NCT05228678 | Unknown

• 1 other identifier: post COVID_19 and dyspnea
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU)

Conditions

covid_19 Patients

Keywords

post covid_19,dyspnea, cardiopulmonary exercise

Outcome Measures

Primary Outcomes (1)

• Assessment of 1. Aerobic capacity 2. Total Lung Capacity (TLC)

  Aerobic capacity measured as peak oxygen uptake Total lung capacity measured by spirometry

  two years

Secondary Outcomes (1)

• Assessment of Walking capacity

  two years

Study Arms (2)

Dyspnea group

Patients with prior diagnosis of COVID-19 and present with persistent dyspnea after 12 weeks of occurrence of symptoms every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: - 1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals. 2. The following parameters observed: 1. Metabolic response * Oxygen consumption VO2 (ml/ min): * P ETO2: Is the end-tidal O2 tension as measured from the exhaled air. * P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise. * Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy 2. Ventilatory response * Minute ventilation : * Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum * Tidal volume (VT): * Respiratory frequency (RF)

Diagnostic Test: cardiopulmonary exercise tests

Control group

Patients with prior diagnosis of COVID-19, fully recovered, without persistent dyspnea every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: - 1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals. 2. The following parameters observed: 1. Metabolic response * Oxygen consumption VO2 (ml/ min): * P ETO2: Is the end-tidal O2 tension as measured from the exhaled air. * P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise. * Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy 2. Ventilatory response * Minute ventilation : * Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum * Tidal volume (VT): * Respiratory frequency (RF)

Diagnostic Test: cardiopulmonary exercise tests

Interventions

cardiopulmonary exercise tests DIAGNOSTIC_TEST

Spirometry * forced expiratory volume in 1 second (FEV1) % predicted, * forced vital capacity (FVC)% predicted, * forced expiratory volume in 1 second /forced vital capacity FEV1 /FVC

Also known as: spirometry

Control group; Dyspnea group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who are diagnosed as post covid\_19 who were admittted to isolation unit of Assiut University Hospitals or visit the post covid\_19 outpatient clinic

You may qualify if:

• Confirmed or clinically and radiologically highly suspected Covid19-infection
• Symptom duration at least 12 weeks following first occurrence of symptoms
• Patients with dyspnea score 2, 3 and 4 on mMRC
• No other disease that better could explain the symptoms (dyspnea) than Covid-19

You may not qualify if:

• Age \<18
• pregnant women
• terminally ill patients
• active covid-19 infection
• previous known severe pulmonary or heart disease
• inability to perform pulmonary function or cardiopulmonary exercise tests.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 RESULT

• Carod-Artal FJ. Post-COVID-19 syndrome: epidemiology, diagnostic criteria and pathogenic mechanisms involved. Rev Neurol. 2021 Jun 1;72(11):384-396. doi: 10.33588/rn.7211.2021230. English, Spanish.

  PMID: 34042167 RESULT

• Fernandez-de-Las-Penas C, Palacios-Cena D, Gomez-Mayordomo V, Florencio LL, Cuadrado ML, Plaza-Manzano G, Navarro-Santana M. Prevalence of post-COVID-19 symptoms in hospitalized and non-hospitalized COVID-19 survivors: A systematic review and meta-analysis. Eur J Intern Med. 2021 Oct;92:55-70. doi: 10.1016/j.ejim.2021.06.009. Epub 2021 Jun 16.

  PMID: 34167876 RESULT

• Radtke T, Crook S, Kaltsakas G, Louvaris Z, Berton D, Urquhart DS, Kampouras A, Rabinovich RA, Verges S, Kontopidis D, Boyd J, Tonia T, Langer D, De Brandt J, Goertz YMJ, Burtin C, Spruit MA, Braeken DCW, Dacha S, Franssen FME, Laveneziana P, Eber E, Troosters T, Neder JA, Puhan MA, Casaburi R, Vogiatzis I, Hebestreit H. ERS statement on standardisation of cardiopulmonary exercise testing in chronic lung diseases. Eur Respir Rev. 2019 Dec 18;28(154):180101. doi: 10.1183/16000617.0101-2018. Print 2019 Dec 31.

  PMID: 31852745 RESULT

• Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.

  PMID: 33735374 RESULT

MeSH Terms

Conditions

Dyspnea

Interventions

Exercise Test; Spirometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Alaa S Ali, assistant lecturer

CONTACT

01064336300; a_s_a.1990@yahoo.com

Maiada K hashem, lecturer

CONTACT

01006559662; maiada.hashem@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: February 8, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: April 1, 2024
• Last Updated: February 23, 2022

Record last verified: 2022-02