Covid19NCT04713540
Rehabilitation in Intensive Care Unit
An observational study of Covid19, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to evaluate the respiratory functions of patients who were hospitalized in intensive care due to Covid-19 and given respiratory rehabilitation, in-bed positioning, and early mobilization, and the time of leaving the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with covid-19
Who may be able to join
- Being over the age of 18
- Those who have been hospitalized since 11.01.2020
- Those who have been consulted in the physical therapy clinic since 11.01.2020
Who cannot join
- Fever ˃38.0 °
- Initial consultation time ˂7 days
- Those with ≤3 days from the onset of the disease to shortness of breath
- Chest radiographic scans showing 50% progression within 24 to 48 hours
- With Spo2 level ≤95%
- Resting blood pressure ˂90 / 60 (1mmHg = 0.133kPa) or ˃140 / 90mmHg.
- -˃100 heart rate per minute
- Those with moderate and / or severe heart disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkor Dr. Sadi Konuk Research and Training hospital
Istanbul, 34147
About this study
Official title: The Intensive Care Rehabilitation Experiences of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients of Pandemic Hospital in Turkey
It was aimed to evaluate the respiratory functions of patients who were hospitalized in intensive care due to Covid-19 and given respiratory rehabilitation, in-bed positioning, and early mobilization, and the time of leaving the intensive care unit.
Read the detailed description
According to the clinical classification of the World Health Organization, COVID-19; It manifests itself in a wide spectrum, ranging from mild illness, Pneumonia, Severe pneumonia, Acute respiratory distress syndrome (ARDS), to Sepsis and septic shock, resulting in death. In the presence of acute respiratory failure, a decrease in lung compliance leads to increased respiratory work, impaired blood oxygenation, and rapid and superficial breathing patterns. In this case, minimizing inspiratory effort and maximizing the mechanical efficiency of breathing is the most important approach of treatment. In these clinical conditions, the strength of the respiratory muscles may also be reduced.
The challenge of COVID-19 requires a multidisciplinary approach. Rehabilitative intervention should be a part of the treatment pathway from the early stages of the disease. There is an urgent need to build information based on the most effective non-pharmacological measures to ensure the earliest discharge and best recovery after complex COVID-19 infection. Multimodal rehabilitation at all stages of the disease should be part of a holistic medical approach, but there is still no consensus on the timing and type of intervention.
Early physiotherapy in early-onset acute respiratory distress syndrome in the ICU is a critical therapeutic tool to reduce the complications of immobilization in critical diseases such as myopathy, neuropathy and ventilator dependence. Benefits include improved residual respiration, musculoskeletal system, neurological and psychological function; It prevents re-hospitalizations in the medium and long term, improves health status and improves the perceived quality of life after discharge. In an acute setting, interventions can also motivate active recipients to participate in rehabilitation pathways and improve adherence to treatment after discharge.
Serious cases of COVID-19 are associated with the consequences of respiratory support and rehabilitation needs related to prolonged immobility and bed rest. These can include:
Impaired lung function;
- physical impairment and muscle weakness; Delirium and other cognitive disorders; Impaired swallowing and communication; and
- Mental health disorders and psychosocial support needs. Based on this information, we aimed to investigate whether respiratory rehabilitation, positioning, normal joint movement exercises and early mobilization are effective in the treatment of Covid-19.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Glaskow coma scale
The Scale was described in 1974 by Graham Teasdale and Bryan Jennett (Assessment of coma and impaired consciousness. A practical scale. Lancet 1974; 2:81-4.) as a way to communicate about the level of consciousness of patients with an acute brain injury.
Measured: Change from Baseline Glaskow coma scale at 6 months
APACHE II
APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system (Knaus et al., 1985),[1] one of several ICU scoring systems. It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.
Measured: Change from Baseline mMRC Dyspnea Scale at 6 months
mMRC Dyspnea Scale
The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. Describes baseline dyspnea, but does not accurately quantify response to treatment of chronic obstructive pulmonary disease (COPD).
Measured: Change from Baseline mMRC Dyspnea Scale at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Retrospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sibel Caglar Okur, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Sibel Çağlar, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713540
- Sponsor's protocol ID
- intensive care unit
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intensive Care Rehabilitation Experiences of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients of Pandemic Hospital in Turkey
- ClinicalTrials.gov ID
- NCT04713540
- Acronym / sponsor ID
- intensive care unit
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 19 Jan 2021 (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.
It was aimed to evaluate the respiratory functions of patients who were hospitalized in intensive care due to Covid-19 and given respiratory rehabilitation, in-bed positioning, and early mobilization, and the time of leaving the intensive care unit.
Detailed description
According to the clinical classification of the World Health Organization, COVID-19; It manifests itself in a wide spectrum, ranging from mild illness, Pneumonia, Severe pneumonia, Acute respiratory distress syndrome (ARDS), to Sepsis and septic shock, resulting in death. In the presence of acute respiratory failure, a decrease in lung compliance leads to increased respiratory work, impaired blood oxygenation, and rapid and superficial breathing patterns. In this case, minimizing inspiratory effort and maximizing the mechanical efficiency of breathing is the most important approach of treatment. In these clinical conditions, the strength of the respiratory muscles may also be reduced.
The challenge of COVID-19 requires a multidisciplinary approach. Rehabilitative intervention should be a part of the treatment pathway from the early stages of the disease. There is an urgent need to build information based on the most effective non-pharmacological measures to ensure the earliest discharge and best recovery after complex COVID-19 infection. Multimodal rehabilitation at all stages of the disease should be part of a holistic medical approach, but there is still no consensus on the timing and type of intervention.
Early physiotherapy in early-onset acute respiratory distress syndrome in the ICU is a critical therapeutic tool to reduce the complications of immobilization in critical diseases such as myopathy, neuropathy and ventilator dependence. Benefits include improved residual respiration, musculoskeletal system, neurological and psychological function; It prevents re-hospitalizations in the medium and long term, improves health status and improves the perceived quality of life after discharge. In an acute setting, interventions can also motivate active recipients to participate in rehabilitation pathways and improve adherence to treatment after discharge.
Serious cases of COVID-19 are associated with the consequences of respiratory support and rehabilitation needs related to prolonged immobility and bed rest. These can include:
Impaired lung function;
- physical impairment and muscle weakness; Delirium and other cognitive disorders; Impaired swallowing and communication; and
- Mental health disorders and psychosocial support needs. Based on this information, we aimed to investigate whether respiratory rehabilitation, positioning, normal joint movement exercises and early mobilization are effective in the treatment of Covid-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with covid-19
Key inclusion criteria (3 listed)
- Being over the age of 18
- Those who have been hospitalized since 11.01.2020
- Those who have been consulted in the physical therapy clinic since 11.01.2020
Key exclusion criteria (8 listed)
- Fever ˃38.0 °
- Initial consultation time ˂7 days
- Those with ≤3 days from the onset of the disease to shortness of breath
- Chest radiographic scans showing 50% progression within 24 to 48 hours
- With Spo2 level ≤95%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glaskow coma scale
Time frame: Change from Baseline Glaskow coma scale at 6 months
The Scale was described in 1974 by Graham Teasdale and Bryan Jennett (Assessment of coma and impaired consciousness. A practical scale. Lancet 1974; 2:81-4.) as a way to communicate about the level of consciousness of patients with an acute brain injury.
APACHE II
Time frame: Change from Baseline mMRC Dyspnea Scale at 6 months
APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system (Knaus et al., 1985),[1] one of several ICU scoring systems. It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.
mMRC Dyspnea Scale
Time frame: Change from Baseline mMRC Dyspnea Scale at 6 months
The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. Describes baseline dyspnea, but does not accurately quantify response to treatment of chronic obstructive pulmonary disease (COPD).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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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.
Sibel Çağlar principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Contact Sibel Çağlar (+905333365651, sibelcaglarokur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glaskow coma scale (time frame: Change from Baseline Glaskow coma scale at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2021.