Rehabilitation in Intensive Care Unit

• ClinicalTrials.gov Identifier: NCT04713540
• Recruitment Status: Recruiting
• First Posted: January 19, 2021
• Last Update Posted: January 20, 2021
• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Information provided by (Responsible Party): Sibel Caglar Okur, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Description

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.

Condition or disease
Covid19

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

• Study Type: Observational
• Estimated Enrollment: 58 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Intensive Care Rehabilitation Experiences of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients of Pandemic Hospital in Turkey
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: April 1, 2021
• Estimated Study Completion Date: May 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with covid-19

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

Contacts and Locations

Contacts

Contact: Sibel Çağlar; +905333365651; sibelcaglarokur@gmail.com

Contact: Tuba Altun; +905525780411; tubasaltun@gmail.com

Locations

Turkey

Bakirkor Dr. Sadi Konuk Research and Training hospital; Recruiting

Istanbul, Turkey, 34147

Sponsors and Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

• Principal Investigator: Sibel Çağlar; Bakırkoy Dr. Sadi Konuk Training and Research Hospital

More Information

• Responsible Party: Sibel Caglar Okur, Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT04713540
• Other Study ID Numbers: intensive care unit
• First Posted: January 19, 2021
• Last Update Posted: January 20, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No