COVID-19 Acute Respiratory Distress Syndrome
Conditions
Brief summary
the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2
Interventions
PROCEDUREprolonged prone position ventilation
patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \- American Society of Anesthesiologists (ASA) physical status II- III. * Sex (male and females). * Age 18 -80 years. * Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of \<150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight * mechanical ventilation for less than 36 hours
Exclusion criteria
* \- Contraindication for prone positioning * increased intracranial tension. * face trauma or surgery. * Recent Deep venous thrombosis * Unstable spine, femur, or pelvic fractures * Mean arterial pressure \< 65 mm Hg * Pregnant women * Pneumothorax * Prone positioning before inclusion * Those returned to supine position before completing the session time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of successful weaning | 28 days | how many patients successfully extubated, hospital survival, ICU stay |
| Incidence of complications | 28 days | Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of oxygenation | 28 days | mean value of change in PaO2/FiO2 ratio and static lung compliance before and after 3 successive proning cycles |
Countries
Egypt
Outcome results
None listed