Clinical trial NCT04713540: Rehabilitation in Intensive Care Unit
Official title: The Intensive Care Rehabilitation Experiences of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients of Pandemic Hospital in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with covid-19

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Glaskow coma scale
timeFrame: Change from Baseline Glaskow coma scale at 6 months
measure: APACHE II
timeFrame: Change from Baseline mMRC Dyspnea Scale at 6 months
measure: mMRC Dyspnea Scale
timeFrame: Change from Baseline mMRC Dyspnea Scale at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkor Dr. Sadi Konuk Research and Training hospital
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: Sibel Çağlar
role: PRINCIPAL_INVESTIGATOR
References: