Rehabilitation in Intensive Care Unit

Covid19 Clinical Trial

Official title:

The Intensive Care Rehabilitation Experiences of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients of Pandemic Hospital in Turkey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04713540
• Other study ID #: intensive care unit
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: January 2021
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: Sibel Çaglar
• Phone: +905333365651
• Email: sibelcaglarokur[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: May 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Turkey	Bakirkor Dr. Sadi Konuk Research and Training hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline Glaskow coma scale at 6 months
Primary	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.	Change from Baseline mMRC Dyspnea Scale at 6 months
Primary	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).	Change from Baseline mMRC Dyspnea Scale at 6 months