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Completed

NCT Number: NCT04854863

Respiratory Muscles After Hospitalisation for COVID-19

Fatigue and exercise intolerance after survived COVID-19-infection might be related to weakness of the respiratory muscles especially following invasive mechanical ventilation in the Intensive Care Unit.

The aim of the project is to measure respiratory muscle function and strength in our respiratory physiology laboratory (Respiratory Physiology Laboratory, Department of Pneumology and Intensive Care Medicine, Head: Professor Michael Dreher) in patients who survived a severe COVID-19-infection (25 with a severe course requiring mechanical ventilation in the intensive care unit, 25 with a moderate-severe course requiring administration of supplemental oxygen only, respectively).

Based on this data the aim is to develop a model which determines the severity, pathophysiology and clinical consequences of respiratory muscle dysfunction in patients who had been hospitalised for COVID-19.

This will potentially prove the importance of a dedicated pulmonologic rehabilitation with respiratory muscle strength training in patients who had been hospitalised for COVID-19.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jens Spiesshoefer

Aachen, North Rhine-Westphalia, Germany

About this study

The aim of the present project is to comprehensively measure respiratory muscle function and strength in patients who survived a hospitalisation for a severe COVID-19-infection (25 with a severe course requiring mechanical ventilation in the intensive care unit, 25 with a moderate-severe course requiring administration of supplemental oxygen only, respectively).

We intend to recruit 50 patients during their regular follow up appointments (12 months and 24 months after their discharge from the hospital) in our pulmonology outpatient-clinic. Patients fulfilling the criterions of inclusion and exclusion will be included.

Patients will undergo a series of measurements on one day in our respiratory physiology laboratory (Respiratory Physiology Laboratory, Department of Pneumology and Intensive Care Medicine, Head: Professor Michael Dreher). Patients will be asked to complete a questionnaire, followed by some examinations comprising spirometry by bodyplethysmography, exercise endurance, capillary blood gas analyses, measurement of maximum inspiratory and expiratory mouth pressures, dynamometric measurement of arm and leg strength, diaphragm ultrasound, magnetic stimulation of the phrenic and lower thoracic nerves with invasive recording of twitch transdiaphragmatic pressure and markers of systemic inflammation based on in depth analyses of blood samples that will be obtained.

Based on this data the aim is to develop a model which determines the severity, pathophysiology and clinical consequences of respiratory muscle dysfunction in patients who had been hospitalised for COVID-19.

This will potentially prove the importance of a dedicated pulmonologic rehabilitation with respiratory muscle strength training in patients who had been hospitalised for COVID-19.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 patients with survived COVID-19-infection (25 with a severe course requiring mechanical ventilation in the intensive care unit, 25 with a moderate-severe course requiring administration of supplemental oxygen only, respectively)
  • Patients aged at least 18 years, who are mentally and physically able to consent and participate into the study

Exclusion criteria

  • Diagnosis of another disease, which causes a permanent increase in carbon dioxide level in the blood (chronic hypercapnia) or a permanent combined lung weakness (particularly a neuromuscular disease)
  • Body-mass-index (BMI) >40
  • Expected absence of active participation of the patient in study-related measurements
  • Alcohol or drug abuse
  • Metal implant in the body that is not MRI compatible (NON MRI compatible pacemaker, implantable defibrillator, cervical implants, e.g. brain pacemakers etc.)
  • Slipped disc
  • Epilepsy
  • Bound to a wheel chair
  • Patients who are mentally and physically unable to consent and participate into the study
  • Patients in an interdependence or with an employment contract with the principal investigator, Co-PI or his deputy.
  • Emergency hospital stay in the last 4 weeks preceding the day of the measurements

Treatment and study plan

Comprehensive assessment of respiratory muscle function.

Diagnostic Test

Comprehensive assessment of respiratory muscle function to the point of its invasive assessment with recordings of twitch transdiaphragmatic pressure in response to magnetic phrenic nerve stimulation and stimulation of the lower thoracic nerve roots.

Primary outcomes

  1. Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots

    Time frame: 2 years

    Recording of twitch transdiaphragmatic pressure (Unit: Pressure in cmH2O)

  2. Respiratory mouth pressures

    Time frame: 2 years

    Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)

Secondary outcomes

  1. Diaphragm ultrasound

    Time frame: 2 years

    Comprehensive evaluation of diaphragm excursion (amplitude during tidal breathing, sniff maneuver and maximal inspiration in cm, corresponding velocity in cm/sec, respectively) and thickening on ultrasound (thickness at functional residual capacity, at total lung capactiy in cm), Markers of Diaphragm excursion and thickening will be combined to classify diaphragm function as normal, mildly, moderately or severly impaired.

  2. Exercise intolerance

    Time frame: 2 years

    Comprehensive evaluation of symptoms (breathlesness based on NYHA class, on a visual scale ranging from 1-10, respectively) and exercise capacity (6 minute walking distance). These measurements will be combined to classifiy patients as presenting with exercise intolerance or no exercise intolerance.

  3. Analyses of markers of systemic inflammation (interleukin levels in ng/ml, TNF alpha in ng/ml, CRP in mg/L; immune phenotyping of inflammatory cells, most importantly whilte blood cell subtypes in %)

    Time frame: 2 years

    Analyses of markers of systemic inflammation based on blood samples taken. These measurements will be combined to classify patients as having increased or normal levels of systemic inflammation.

  4. Lung function

    Time frame: 2 years

    Comprehensive assessment of lung function by bodyplethysmography (most importantly forced vital capacity, forced expiratory volume after 1 second, intrathoracic gas volume, residual volume) and capillary blood gas analysis (most importantly pO2 in mmHG and pCO2 in mmHG). These measurements will be combined to classify patients as showing normal, restrictive, obstructive lung function impairment, as being hypoxic, hypercapnic, respectively.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Respiratory Muscle Function After Hospitalisation for COVID-19 -Pathophysiological Model on Severity, Determinants and Clinical Consequences of Respiratory Muscle Strength Impairment in Patients Who Had Been Hospitalised for COVID-19-

Acronym: REMAP-COVID-19

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2021
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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