COVID-19COVENTRYNCT04373811
One-Year Quality of Life and Functional Prognosis of COVID-19 Patients in Post-ICU Setting
An observational study of COVID-19 and ICU Acquired Weakness, run by Fondation Hôpital Saint-Joseph at 3 sites in France.
Trial summary
The COVID-19 disease has been subject to numerous publications since its emergence. Almost 20% of people suffering from COVID-19 develop severe to critical symptoms and require hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is the main reason for admission in ICU of these patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19, ICU Acquired Weakness, Weaning Failure
- What is being tested?
- Lung ultrasound and Muscle ultrasound
- How many people
- 65 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Apr 2020to 31 Dec 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were initially hospitalized in ICU for COVID-19 and then admitted in a post-ICU setting for difficult weaning purpose.
Who may be able to join
- Patient initially hospitalized in ICU for COVID-19;
- Admitted in post-ICU setting (difficult-to-wean unit);
- Age > 18 years old;
- Membership of a social insurance sheme;
- Medical prescription of early mobilization;
- Patient or relative provides consent.
Who cannot join
- Known pregnancy ;
- Person subject to judicial health protection;
- Patient under legal guardianship or curatorship;
- Contraidication for early mobilization;
- Decision to withhold lifesustaining treatment.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier de Béthune
Beuvry, Hauts-de-France, 62660
Hôpital Forcilles
Férolles-Attilly, Île-de-France Region, 77150
APHP - Hôpital Universitaire Pitié-Salpétrière
Paris, Île-de-France Region, 75013
About this study
Official title: Quality of Life and Functional Prognosis at One Year of Patients With COVID-19 Admitted in Post-ICU Setting
The COVID-19 disease has been subject to numerous publications since its emergence. Almost 20% of people suffering from COVID-19 develop severe to critical symptoms and require hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is the main reason for admission in ICU of these patients. Therapeutic strategies implemented for the management of critically-ill patients may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead to long-term disabilities expressing trough dependence and quality of life impairment of survivors.
The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose.
Ancillary studies aim to assess the course of muscle function (atrophy, structural modifications), lung function (loss of aeration) and safety of early mobilization.
Read the detailed description
SARS-Cov-2, a virus causing a new infectious disease called COVID-19, has been subject to numerous publications since its emergence. Almost 20% of people infected with SARS-Cov-2 develop severe to critical symptoms and required hospitalization, often in Intensive Care Unit (ICU).
Respiratory failure is the main reason for admission in ICU of patients with COVID-19, which develop an Acute Respiratory Distress Syndrome (ARDS). Respiratory failure may be associated to liver, renal, coagulation and hemodynamic failure.
Therapeutic strategies implemented for the management of critically-ill patients with COVID-19 may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW), as studied in other ICU population.
The muscular and functional impairments of patients are associated to a longer duration of mechanical ventilation and hospital length of stay and increased mortality. Long-term impacts are also reported like dependence and quality of life impairment of survivors.
The COVID-19 pandemic currently leads to an increasing number of ICU admission in France with a high risk of settings saturation. Specialized settings for post-ICU rehabilitation are preparing to early receive difficult-to-wean patients with ICUAW after admission in ICU for severe or critical form of COVID-19.
To our best knowledge, no data is obviously available regarding at the future of these patients in terms of quality of life, dependence or survival. Moreover, no short-term data are available concerning the course of lung damages and muscle function after ICU stay. The safety of early mobilization usually delivered in patients admitted to post-ICU settings has never been assessed in patients with COVID-19.
The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose.
Ancillary studies aim to assess course of muscle function (atrophy, structure modification), lung function (loss of aeration) and safety of early mobilization.
- Conditions
- COVID-19, ICU Acquired Weakness, Weaning Failure
- Being tested
- Lung ultrasound, Muscle ultrasound
- Keywords
- COVID-19, ICU, ICUAW, Lung Ultrasound, Muscle Ultrasound, Quality of life, Physiotherapy, Diaphragm Ultrasound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Lung ultrasound will be performed in 12 thorax area: anterior, lateral and posterior, each area divided in superior and inferior area, for each hemithorax.
Lung Ultrasound Score (lung aeration) will be recorded using a convex probe with a transverse view. Presence of pleural thickening and subpleural consolidations will be recorded.
Muscle ultrasoundDiagnostic test
Diaphragm ultrasound will be performed using intercostal view with a linear probe at the zone of apposition for assessing diaphragm thickness and thickening and subcostal anterior view with convex probe to assess diaphragm excursion.
Thickness of vastus intermedius, rectus femori and tibialis anterior will be measured using ultrasound linear probe. Cross-sectionnal area and echogeneicity of rectus femori and tibialis anterior will be measured using ultrasound linear probe. Penation angle of rectus femori will be assessed using ultrasound linear probe.
| Study group | Role | What they receive |
|---|---|---|
| Principal cohort | Quality of life, autonomy and survival will be assessed at one year on 50 patients. Safety of early mobilization in post-ICU setting and Medical Reasearch Council (MRC) sum score will be assessed during hospitalization. | |
| Lung cohort | Lung Ultrasound will be carried out on the first 38 patients of the principal cohort. Receives: Diagnostic Test: Lung ultrasound | |
| Muscle cohort | Muscle Ultrasound will be carried out on the first 27 patients of the principal cohort. Receives: Diagnostic Test: Muscle ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean in quality of life score at one year on the Short Form Health Survey (SF-36)
Quality of life will be assessed using Short Form Health Survey (SF-36) through a phone call at one year. SF-36 score range from 0 to 100, 100 indicating a better quality of life.
Measured: 1 year
Secondary outcomes (10)
Mean in autonomy score on the Activities Daily Living (ADL) scale
Autonomy will be assessed using Activities Daily Living (ADL) scale through a phone call at one year and six months.
ADL scale range from 0 to 6, 6 indicating a better autonomy in activities daily living.
Measured: At enrollement and 1 year
Survival rate
Survival will be assessed using the death registry query and phone call for vital status recording at six months and one year. Survival rate will be expressed as a survival function using Kaplan Meier method.
Measured: 1 year
Change from baseline in lung ultrasound aeration score
Lung aeration will be assessed using the Lung Ultrasound Score (LUS). Patient is in semi-recumbent position (30°). Lung ultrasound will be performed in 12 thorax area: anterior, lateral and posterior, each area divided in superior and inferior area, for each hemithorax.
Lung Ultrasound Score will be recorded using a convex probe with a transverse view.
For each thorax area a subscore is calculated: 0 = normal profil; 1 = multiple and well-defined B-lines; 2 = confluent B-lines; 3 = lung consolidation.
Sum of this subscores allows calculation of the total score out of 60. Presence of pleural thickening and subpleural consolidations will be also recorded.
Measured: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Change from baseline in diaphragm ultrasound thickness and excursion
Diaphragm Ultrasound will be used to assess diaphragm thickness and excursion. Patient is in semi-recumbent position (30°). Diaphragm thickness will be performed using intercostal view with a linear probe at the zone of apposition for assessing diaphragm thickness. M-Mode will be used to measure diaphragm thickness at inspiratory time (maximal inspiration) and expiratory time (maximal expiration).
Diaphragm excursion will be measured using a subcostal anterior view with convex probe. Excursion measurement is performed in M-mode as the distance between end-inspiration and end-expiration.
Three measures of both DTF and excursion will performed and the better will be kept.
Measured: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle thickness
Muscle ultrasound measurements will be performed using a linear probe with a transverse view.
Thickness (cm) of vastus intermedius, rectus femori and tibialis anterior will be measured.
Measured: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle cross-sectionnal area
Muscle ultrasound measurements will be performed using a linear probe with a transverse view.
Cross-sectionnal area (CSA) (cm^2) of rectus femori and tibialis anterior will be measured.
Measured: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle echogeneicity
Muscle ultrasound measurements will be performed using a linear probe with a transverse view.
Echogeneicity (0 to 255) of rectus femori and tibialis anterior will be measured using Image J software. Penation angle of rectus femori will be assessed.
is used to measure muscle thicknesses, CSA and echogeneicity. Longitudinal view is used to measure angle of pennation.
Measured: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle pennation
Muscle ultrasound measurements will be performed using a linear probe with a longitudinal view.
Penation angle (°) of rectus femori will be assessed.
Measured: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in Medical Research Council (MRC) sum score
MRC sum score evaluates strength in three muscle groups of all four limbs. A score between 0 and 5 is assigned to each of them, which renders a maximum total score of 60.
Measured: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Prevalence of adverse outcomes during early mobilization
Number of adverse outcomes during early mobilization of patients will recorded at each mobilization session. Prevalence of adverse outcomes is expressed as the number of adverse outcomes divided by the number of early mobilization sessions.
Measured: From date of enrollement up to 30 days (date of estimated post-ICU discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start16 Apr 2020
- Primary completion13 Jul 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Forcilles
- Responsible party
- Sponsor
- Investigators
- Aymeric LE NEINDRE, PT, PhD, Principal investigator, Hopital Forcilles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373811
- Sponsor's protocol ID
- COVENTRY
- Acronym
- COVENTRY
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be openly available in "figshare".
Publications
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.
PubMed 32091533Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available.
PubMed 32159735Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
PubMed 24758618Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30.
PubMed 27025938Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
PubMed 19633538Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.
PubMed 32166346Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.
PubMed 26211979Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
PubMed 14044222Flaatten H, Kvale R. Survival and quality of life 12 years after ICU. A comparison with the general Norwegian population. Intensive Care Med. 2001 Jun;27(6):1005-11. doi: 10.1007/s001340100960.
PubMed 11497132Cartwright MS, Kwayisi G, Griffin LP, Sarwal A, Walker FO, Harris JM, Berry MJ, Chahal PS, Morris PE. Quantitative neuromuscular ultrasound in the intensive care unit. Muscle Nerve. 2013 Feb;47(2):255-9. doi: 10.1002/mus.23525. Epub 2012 Oct 5.
PubMed 23041986
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Functional Prognosis at One Year of Patients With COVID-19 Admitted in Post-ICU Setting
- ClinicalTrials.gov ID
- NCT04373811
- Acronym / sponsor ID
- COVENTRY / COVENTRY
- Conditions
- COVID-19, ICU Acquired Weakness, Weaning Failure
- Keywords
- COVID-19, ICU, ICUAW, Lung Ultrasound, Muscle Ultrasound, Quality of life, Physiotherapy, Diaphragm Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Hopital Forcilles
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 May 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.
The COVID-19 disease has been subject to numerous publications since its emergence. Almost 20% of people suffering from COVID-19 develop severe to critical symptoms and require hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is the main reason for admission in ICU of these patients. Therapeutic strategies implemented for the management of critically-ill patients may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead to long-term disabilities expressing trough dependence and quality of life impairment of survivors.
The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose.
Ancillary studies aim to assess the course of muscle function (atrophy, structural modifications), lung function (loss of aeration) and safety of early mobilization.
Detailed description
SARS-Cov-2, a virus causing a new infectious disease called COVID-19, has been subject to numerous publications since its emergence. Almost 20% of people infected with SARS-Cov-2 develop severe to critical symptoms and required hospitalization, often in Intensive Care Unit (ICU).
Respiratory failure is the main reason for admission in ICU of patients with COVID-19, which develop an Acute Respiratory Distress Syndrome (ARDS). Respiratory failure may be associated to liver, renal, coagulation and hemodynamic failure.
Therapeutic strategies implemented for the management of critically-ill patients with COVID-19 may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW), as studied in other ICU population.
The muscular and functional impairments of patients are associated to a longer duration of mechanical ventilation and hospital length of stay and increased mortality. Long-term impacts are also reported like dependence and quality of life impairment of survivors.
The COVID-19 pandemic currently leads to an increasing number of ICU admission in France with a high risk of settings saturation. Specialized settings for post-ICU rehabilitation are preparing to early receive difficult-to-wean patients with ICUAW after admission in ICU for severe or critical form of COVID-19.
To our best knowledge, no data is obviously available regarding at the future of these patients in terms of quality of life, dependence or survival. Moreover, no short-term data are available concerning the course of lung damages and muscle function after ICU stay. The safety of early mobilization usually delivered in patients admitted to post-ICU settings has never been assessed in patients with COVID-19.
The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose.
Ancillary studies aim to assess course of muscle function (atrophy, structure modification), lung function (loss of aeration) and safety of early mobilization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Principal cohort | – | –Quality of life, autonomy and survival will be assessed at one year on 50 patients. Safety of early mobilization in post-ICU setting and Medical Reasearch Council (MRC) sum score will be assessed during hospitalization. |
| Lung cohort | – | Diagnostic Test: Lung ultrasoundLung Ultrasound will be carried out on the first 38 patients of the principal cohort. |
| Muscle cohort | – | Diagnostic Test: Muscle ultrasoundMuscle Ultrasound will be carried out on the first 27 patients of the principal cohort. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were initially hospitalized in ICU for COVID-19 and then admitted in a post-ICU setting for difficult weaning purpose.
Key inclusion criteria (6 listed)
- Patient initially hospitalized in ICU for COVID-19;
- Admitted in post-ICU setting (difficult-to-wean unit);
- Age > 18 years old;
- Membership of a social insurance sheme;
- Medical prescription of early mobilization;
Key exclusion criteria (5 listed)
- Known pregnancy ;
- Person subject to judicial health protection;
- Patient under legal guardianship or curatorship;
- Contraidication for early mobilization;
- Decision to withhold lifesustaining treatment.
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 |
|---|---|---|
| Lung ultrasoundLung ultrasound will be performed in 12 thorax area: anterior, lateral and posterior, each area divided in superior and inferior area, for each hemithorax. Lung Ultrasound Score (lung aeration) will be recorded using a convex probe with a transverse view. Presence of pleural thickening and subpleural consolidations will be recorded. | Diagnostic test | Lung cohort |
| Muscle ultrasoundDiaphragm ultrasound will be performed using intercostal view with a linear probe at the zone of apposition for assessing diaphragm thickness and thickening and subcostal anterior view with convex probe to assess diaphragm excursion. Thickness of vastus intermedius, rectus femori and tibialis anterior will be measured using ultrasound linear probe. Cross-sectionnal area and echogeneicity of rectus femori and tibialis anterior will be measured using ultrasound linear probe. Penation angle of rectus femori will be assessed using ultrasound linear probe. | Diagnostic test | Muscle cohort |
Primary outcome
Mean in quality of life score at one year on the Short Form Health Survey (SF-36)
Time frame: 1 year
Quality of life will be assessed using Short Form Health Survey (SF-36) through a phone call at one year. SF-36 score range from 0 to 100, 100 indicating a better quality of life.
10 secondary outcomes
Mean in autonomy score on the Activities Daily Living (ADL) scale
Time frame: At enrollement and 1 year
Survival rate
Time frame: 1 year
Change from baseline in lung ultrasound aeration score
Time frame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Change from baseline in diaphragm ultrasound thickness and excursion
Time frame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle thickness
Time frame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle cross-sectionnal area
Time frame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle echogeneicity
Time frame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in ultrasound muscle pennation
Time frame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Mean change from baseline in Medical Research Council (MRC) sum score
Time frame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Prevalence of adverse outcomes during early mobilization
Time frame: From date of enrollement up to 30 days (date of estimated post-ICU discharge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 32091533Wu 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.
- Background: PubMed 32159735Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available.
- Background: PubMed 24758618Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
- Background: PubMed 27025938Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30.
- Background: PubMed 19633538Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
- Background: PubMed 32166346Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.
- Background: PubMed 26211979Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 14044222KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
- Background: PubMed 11497132Flaatten H, Kvale R. Survival and quality of life 12 years after ICU. A comparison with the general Norwegian population. Intensive Care Med. 2001 Jun;27(6):1005-11. doi: 10.1007/s001340100960.
- Background: PubMed 23041986Cartwright MS, Kwayisi G, Griffin LP, Sarwal A, Walker FO, Harris JM, Berry MJ, Chahal PS, Morris PE. Quantitative neuromuscular ultrasound in the intensive care unit. Muscle Nerve. 2013 Feb;47(2):255-9. doi: 10.1002/mus.23525. Epub 2012 Oct 5.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be openly available in "figshare".
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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.
Aymeric LE NEINDRE, PT, PhD principal investigator
Hopital Forcilles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and ICU Acquired Weakness, run by Fondation Hôpital Saint-Joseph at 3 sites in France.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Results are not available in the source record.
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?
Mean in quality of life score at one year on the Short Form Health Survey (SF-36) (time frame: 1 year). 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 NCT04373811, which also lists 11 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 27 Apr 2023.