Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343545
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure in Patients With Suspected COVID-19
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rehab
Brief Summary:
To evaluate through a randomized clinical trial in groupsclusters stepped wedge the impact of specific bundles for disability prevention and early rehabilitation focused on 3 domains ICU Ward and post-discharge on health-related quality of life and other long- and short-term outcomes in critically ill patients affected by hypoxemic acute respiratory failure with suspected COVID-19
Detailed Description:
Patients with severe forms of hypoxemic acute respiratory failure have persistent symptoms after hospital discharge which seem to be mediated mainly by the need for mechanical ventilation One of the main etiologies of hypoxemic acute respiratory failure is still COVID-19 in its endemic form According to the World Health Organization WHO approximately 10 to 20 of people affected by COVID-19 develop persistent symptoms lasting more than 3 months in a condition described as Long COVID 1 These symptoms can affect multiple organ systems including respiratory cardiovascular musculoskeletal and nervous systems and health domains physical and mental domains for example A systematic review identified more than 50 symptoms potentially associated with Long COVID including fatigue muscle weakness cough dyspnea difficulty concentrating anosmia headache joint pain insomnia and anxiety were the most frequently reported Such findings are similar in broader populations including those with other forms of hypoxemic acute respiratory failure
Observational studies demonstrate a consistent association between Long COVID and negative impacts on functionality quality of life hospitalizations and costs Two cohort studies conducted in the United States with COVID-19 hospitalization survivors whose sum totals more than 2700 participants found 60-day rehospitalization rates greater than 15 Notably about 48 of participants in one of these studies were financially distressed by COVID-19
Although the occurrence of prolonged post-COVID symptoms does not depend exclusively on the severity of the initial SARS-CoV-2 infection patients who require hospitalization for severe acute COVID-19 are those who have a higher prevalence of Long COVID and intensity of disabilities In a study of more than 1700 COVID-19 survivors in China more severe COVID-19 cases were associated with a higher risk of persistent symptoms reduced physical capacity muscle weakness reduced ability to diffuse carbon monoxide a test that evaluates the oxygenation capacity of the lungs and an impact on quality of life In this population of severe cases it is believed that the prolonged effects of SARS-CoV-2 infection are added to the physical cognitive and mental health sequelae typically associated with critical illness resulting from organ dysfunctions and intensive treatments for example potentiating the impact on the long-term health of COVID-19 survivors
In scenarios similar to those of severe COVID-19 such as sepsis and acute respiratory distress syndrome the implementation of mechanical ventilation release bundles screening and early rehabilitation while still in the hospital ward the adequate transmission of continuity of care to primary care and the provision of access to rehabilitation after hospital discharge have shown the potential to accelerate the recovery of people affected by sequelae related to critical illnesses However these findings are based on preliminary studies that do not confirm their benefit in a large sample and with adequate methodology In the broadest sense the early initiation of interventions is an essential aspect to improve outcomes When added to the delay in defining the etiology of the hypoxemic acute respiratory condition it is imperative that the measures be applied in an equitable manner in the case of suspected COVID-19 and maintained even if the final diagnosis is not COVID-19 It would be ethically questionable to withdraw a potentially beneficial intervention from an at-risk population merely because it is not COVID-19 given the immense impact of acute respiratory failure on long-term quality of life
Given the current scenario in Brazil with more than 36 million people with a history of SARS-CoV-2 infection it is estimated that more than 1 million people have been affected by Long COVID Given this magnitude of cases it is likely that during the coming years due to the sequelae of COVID-19 the demand on the Unified Health System SUS for physical and mental rehabilitation services will increase In this imminent situation it is essential to investigate effective and pragmatic strategies such as those described above aimed at preventing and rehabilitating sequelae related to Long COVID especially in patients affected by severe forms of COVID-19 Thus a randomized clinical trial the gold standard for evaluating interventions will have the potential to support public policies for post-COVID-19 rehabilitation with accurate and generalizable information to the Brazilian context The inclusion of patients with a suspected but not confirmed condition will allow a greater generalization of the results and early initiation of intervention in patients with other equally relevant pathologies with similar potential benefits
Therefore we propose a process improvement implementation study with a design based on the allocation of hospitals clusters in a sequential manner stepped wedge to evaluate whether the implementation of care bundles in intensive care units wards and post-discharge is capable of improving the quality of life in patients admitted to the ICU with hypoxemic acute respiratory failure within 90 days after discharge hospital
Observational studies demonstrate a consistent association between Long COVID and negative impacts on functionality quality of life hospitalizations and costs Two cohort studies conducted in the United States with COVID-19 hospitalization survivors whose sum totals more than 2700 participants found 60-day rehospitalization rates greater than 15 Notably about 48 of participants in one of these studies were financially distressed by COVID-19
Although the occurrence of prolonged post-COVID symptoms does not depend exclusively on the severity of the initial SARS-CoV-2 infection patients who require hospitalization for severe acute COVID-19 are those who have a higher prevalence of Long COVID and intensity of disabilities In a study of more than 1700 COVID-19 survivors in China more severe COVID-19 cases were associated with a higher risk of persistent symptoms reduced physical capacity muscle weakness reduced ability to diffuse carbon monoxide a test that evaluates the oxygenation capacity of the lungs and an impact on quality of life In this population of severe cases it is believed that the prolonged effects of SARS-CoV-2 infection are added to the physical cognitive and mental health sequelae typically associated with critical illness resulting from organ dysfunctions and intensive treatments for example potentiating the impact on the long-term health of COVID-19 survivors
In scenarios similar to those of severe COVID-19 such as sepsis and acute respiratory distress syndrome the implementation of mechanical ventilation release bundles screening and early rehabilitation while still in the hospital ward the adequate transmission of continuity of care to primary care and the provision of access to rehabilitation after hospital discharge have shown the potential to accelerate the recovery of people affected by sequelae related to critical illnesses However these findings are based on preliminary studies that do not confirm their benefit in a large sample and with adequate methodology In the broadest sense the early initiation of interventions is an essential aspect to improve outcomes When added to the delay in defining the etiology of the hypoxemic acute respiratory condition it is imperative that the measures be applied in an equitable manner in the case of suspected COVID-19 and maintained even if the final diagnosis is not COVID-19 It would be ethically questionable to withdraw a potentially beneficial intervention from an at-risk population merely because it is not COVID-19 given the immense impact of acute respiratory failure on long-term quality of life
Given the current scenario in Brazil with more than 36 million people with a history of SARS-CoV-2 infection it is estimated that more than 1 million people have been affected by Long COVID Given this magnitude of cases it is likely that during the coming years due to the sequelae of COVID-19 the demand on the Unified Health System SUS for physical and mental rehabilitation services will increase In this imminent situation it is essential to investigate effective and pragmatic strategies such as those described above aimed at preventing and rehabilitating sequelae related to Long COVID especially in patients affected by severe forms of COVID-19 Thus a randomized clinical trial the gold standard for evaluating interventions will have the potential to support public policies for post-COVID-19 rehabilitation with accurate and generalizable information to the Brazilian context The inclusion of patients with a suspected but not confirmed condition will allow a greater generalization of the results and early initiation of intervention in patients with other equally relevant pathologies with similar potential benefits
Therefore we propose a process improvement implementation study with a design based on the allocation of hospitals clusters in a sequential manner stepped wedge to evaluate whether the implementation of care bundles in intensive care units wards and post-discharge is capable of improving the quality of life in patients admitted to the ICU with hypoxemic acute respiratory failure within 90 days after discharge hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None