Coronaltitude - Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19

NCT05167357 | Completed

• 1 other identifier: CORONALTITUDE2021
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will examine the extent to which having suffered coronavirus disease 2019 (COVID19) impacts one's sensibility to hypoxia by means of the 'Richalet test'. The aim of the study is to formulate recommendations for advice in altitude mountain medicine for patients having suffered COVID19. To determine any eventual changes in response to hypoxia, performances by participants having suffered COVID-19 and participants having stayed free of COVID-19 will be both compared intra-individually with previous performances (pre-COVID-19 pandemic) and between both groups of subjects. The investigators hypothesize that patients having suffered COVID19 might perform differently on the cardiopulmonary exercise test compared to before the illness. Based on recent research on COVID19 pathophysiology and -patient follow-up, it might be expected that COVID19 alters the response to hypoxia, thus influencing one's acclimatization capabilities at high altitude, albeit reversibly and/or temporarily. Different alterations of response to hypoxia could be observed. The virus causing COVID19, the "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), has the potential to significantly damage the nervous system and to affect cardiorespiratory functions. If SARS-CoV-2 does, similarly to MERS and SARS, induce cardiorespiratory and neurological dysfunction, then COVID19 patients may have impaired hypoxia response after infection and perform worse on the 'Richalet test' in comparison to before the illness. Conversely, reports of high prevalence of dyspnea in patients up to 3 months after SARS-CoV-2 infection, might indicate infection-induced degenerative changes in the carotid bodies, which might lead to sensibilization of the peripheral chemoreceptors to impaired oxygenation. Possibly similar to the impact of aging and smoking on the cardiorespiratory response to hypoxia, this phenomenon of sensibilization could entail an increased hypoxic response in patients having suffered COVID-19. Accordingly, patients might perform better on the 'Richalet test' post-COVID-19 than they did before.

Conditions

Covid19; SARS-CoV2 Infection; Hypoxia, Altitude

Keywords

Hypoxia, high Altitude; Cardiorespiratory injury; Respiratory Tract Infections; Neurological injury; Neurotropism; Acclimatization; High Altitude Effects; High Altitude Illness; Cardiorespiratory Exercise Test; Covid19; SARS-CoV-2; Hypoxia sensibility; Hypoxic response; Carotid bodies; Chemosensitivity; Covid19, pathophysiology; hypoxia at exercise; hypoxic cardiac response at exercise; hypoxic ventilatory response at exercise

Outcome Measures

Primary Outcomes (3)

• desaturation induced by hypoxia at exercise (∆SaO2)

  ∆SaO2, HCRe and HVRe are considered to be indirect measurements of the chemosensitivity and response to hypoxia. HCRe and HVRe are calculated from the ratio of respective increased parameters (CF and RR) over the decrease in arterial oxygen saturation measured in 5 consecutive phases of the hypoxic exercise test.

  Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.

• hypoxic cardiac response at exercise (HCRe)

  See description outcome 1

  Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.

• hypoxic ventilatory response at exercise (HVRe)

  see description outcome 1

  Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.

Secondary Outcomes (1)

• SHAI prediction score

  Assessment over a period of time of a common mountain consultation - around half a day.

Study Arms (2)

COVID+ group

EXPERIMENTAL

As the performance of the Richalet test is done by both arms, the intervention rather is the having undergone COVID19.

Biological: COVID19

Control group / COVID- group

NO INTERVENTION

Performance of the Richalet test is done by both arms, the control in this study here is the having stayed clear of COVID19.

Interventions

COVID19 BIOLOGICAL

Intervention in experimental group (COVID+ group) is the disease itself, compared to the control group (COVID- group). At inclusion, subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan. Moreover, the Richalet test is a cardiorespiratory exercise test on an ergocycle (an electrically braked cycloergometer), whilst continuous measurement by a 12-lead ECG, a blood pressure cuff, a metabograph and an ear pulse oximeter. This, to assess cardiac response, ventilatory response and relevant metabolic parameters (CF, RR, SpO2, volume, BP). Subjects breathes through a mask connected to a gas mixer, which provides a gas mixture with 11,5% oxygen (corresponding to ambient air at an altitude of 4800m) in the hypoxia phases.

Also known as: SARS-CoV-2, Covid, severe acute respiratory syndrome coronavirus 2

COVID+ group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject having stayed clear of COVID19 (COVID-/control group).
• Subject having been well informed and having provided written informed consent before participation.
• Subject covered by social security of some sort.
• Subject with an oxygen saturation of SpO2 \> 95% in ambient air on day of Richalet test performance.
• Subject presenting with no symptoms of COVID19 (anymore) on the day of the experiment.
• Subject having already performed the Richalet hypoxia exercise test as part of the altitude mountain consultation in the years 2015 to 2019 in any of the 13 hospital centers participating at the study.

You may not qualify if:

• Subject with a history of respiratory, cardiovascular, neuromuscular, metabolic or renal pathologies.
• Subject with a history of psychiatric or behavioral disorder.
• Subject covered by L1121-5 to L1121-8 sections of the Public Health regulations (Code de la Santé Publique).
• Subject under guardian- or curatorship.
• Subject without social insurance.
• Subjet under the age of 18.
• Subject refusing to participate in the study.
• Subject diagnosed with an infection by a pathogen other than SARS-CoV-2.

Sponsors & Collaborators

• Institut de Formation et de Recherche en Médecine de Montagne: lead
• University of Paris 13: collaborator
• Ecole Nationale des Sports de Montagne: collaborator

Study Sites (1)

Institut de Formation et de Recherche en Médecine de Montagne (IFREMMONT)

Chamonix, Auvergne-Rhône-Alpes, 74400, France

Location

Related Publications (37)

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MeSH Terms

Conditions

COVID-19; Altitude Sickness; Hypoxia; Respiratory Tract Infections; Trauma, Nervous System

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Wounds and Injuries

Study Officials

• François Lecoq-Jammes, Dr.

  study coordinator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All subjects, whether partaking in the COVID+ group or control group, got the same intervention. As such, the 'intervention' rather is the having undergone COVID19 or not. Involving sanitary reasons surrounding the COVID pandemic, a lack of communication concerning the COVID diagnosis between and to any party would have led to unnecessary health endangerment of concerned parties.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD. Chef de pôle urgence et médecine de montagne

Model Details: From the patients who came for consultation between 2015 and 2020, subjects have been recruited by mail for the Coronaltitude study from the 1st of March (2021) on. Subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan. Both patients answering positively and those answering negatively on the latter question have been included in the study. All included subjects, divided into those having suffered COVID19 (COVID+ group) and those having stayed free of COVID19 (control group), will retake an altitude mountain consultation.

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: December 22, 2021
• Study Start: January 13, 2021
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

FR (1)