]>
IRCT20200723048178N2 IRCT 2021-04-28 Pakistan Institute of Medical Sciences, Islamabad Intermittent CPAP in hypoxemic COVID patients Comparative Trial of Intermittent CPAP use in Hypoxemic Patients with COVID-19 infection 2021-05-02 anticipated 93 Complete https://irct.ir/trial/55771 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized using a "simple" randomization method with "individuals" considered as a single unit. A table of random numbers will be generated using "https://www.randomizer.org/". One set of patients will be labeled as "controls" while the other group will be labeled as the "Interventional Group". No concealment will be carried out (open-label). N/A COVID-19 Infection. Intervention 1: Intervention group: Patients in the intervention group will be applied CPAP masks for two hours in the morning and two hours in the evenings (total four hours), at least six hours apart. The CPAP pressure will be fixed at 5 mmHg. All patients in the interventional group will also receive conventional treatment. Conventional treatment will include the following: 1. Dexamethasone 6 mg intravenous once daily for 10 days, 2. Injection enoxaparin 60 mg subcutaneous once daily during the hospital stay, 3. Antibiotics as per the hospital protocol and physician's discretion, 4. Injection omeprazole 40 mg IV once daily during the hospital stay, 5. Injection Remdesivir 200 mg IV on day one then once daily for 5 to 10 days. Intervention 2: Control group: The control group will receive only the conventional treatment. Conventional treatment will include the following: 1. Dexamethasone 6 mg intravenous once daily for 10 days, 2. Injection enoxaparin 60 mg subcutaneous once daily during the hospital stay, 3. Antibiotics as per the hospital protocol and physician's discretion, 4. Injection omeprazole 40 mg IV once daily during the hospital stay, 5. Injection Remdesivir 200 mg IV on day one then once daily for 5 to 10 days. Yes - There is a plan to make this available What will be shared: All the relevant data will be shared. When: Data will be available for one year following the completion of the study. To whom: Data will be shared with all healthcare workers and policymakers. Conditions: Information may be requested via email to the corresponding author. Data will be shared as SPSS outcome files. Where to obtain: Data will be provided by the corresponding author. It will be shared via email. email: drfarhan992@gmail.com How to obtain: Data may be provided via email on working days (Monday to Friday). It may take 3 to 5 days after the request is made. Comments: None
public Ahmed Farhan
G-8/3, Islamabad
Islamabad Pakistan 44080 +92 51 2331590 drfarhan992@gmail.com Pakistan Institute of Medical Sciences, Islamabad scientific Ahmed Farhan
G-8/3, Islamabad
Islamabad Pakistan 44080 +92 51 2331590 drfarhan992@gmail.com Pakistan Institute of Medical Sciences, Islamabad Pakistan Hospitalized patients with severe COVID-19 infection Patients requiring supplemental oxygen of 10 litres or more 18 years 70 years Both Unco-operative patient Patients with Pneumothorax Patients with Surgical emphysema GCS less than 13 Excessive respiratory secretions Shock J12.81 Pneumonia due to SARS-associated coronavirus Treatment - Devices N/A Intervention group: Patients in the intervention group will be applied CPAP masks for two hours in the morning and two hours in the evenings (total four hours), at least six hours apart. The CPAP pressure will be fixed at 5 mmHg. All patients in the interventional group will also receive conventional treatment. Conventional treatment will include the following: 1. Dexamethasone 6 mg intravenous once daily for 10 days, 2. Injection enoxaparin 60 mg subcutaneous once daily during the hospital stay, 3. Antibiotics as per the hospital protocol and physician's discretion, 4. Injection omeprazole 40 mg IV once daily during the hospital stay, 5. Injection Remdesivir 200 mg IV on day one then once daily for 5 to 10 days. Control group: The control group will receive only the conventional treatment. Conventional treatment will include the following: 1. Dexamethasone 6 mg intravenous once daily for 10 days, 2. Injection enoxaparin 60 mg subcutaneous once daily during the hospital stay, 3. Antibiotics as per the hospital protocol and physician's discretion, 4. Injection omeprazole 40 mg IV once daily during the hospital stay, 5. Injection Remdesivir 200 mg IV on day one then once daily for 5 to 10 days. In-hospital mortality. Timepoint: 28 days after intervention. Method of measurement: A Questionnaire will be used to record the data. The duration of hospital stay. Timepoint: 28 days following the intervention. Method of measurement: A Questionnaire will be used to record the data. The use of non-invasive or invasive mechanical ventilation. Timepoint: 28 days after intervention. Method of measurement: A Questionnaire will be used to record the data. Pakistan Institute of Medical Sciences, Islamabad Approved 2021-04-21 Ethics Committee of Pakistan Institute of Medical Sciences, Islamabad G-8/3, Islamabad Islamabad Punjab Pakistan