A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 244
- Primary Endpoint
- Number of participants within intervention arm whom need endotracheal intubation.
Study Overview
Brief Summary
Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.
Detailed Description
we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at Respiratory Intensive Care Unit (RICU), Chest Department, Assiut University Hospital, Egypt.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation.
Exclusion Criteria
- •Patients will be excluded from the study if they :
- •had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.
Outcomes
Primary Outcomes
Number of participants within intervention arm whom need endotracheal intubation.
Time Frame: 30 days of randomization.
Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR\> 35/min., PaO2/FiO2\<200 mmHg, and respiratory acidosis (pH\<7.30)).
Secondary Outcomes
- Number of days on a ventilator.(30 days of randomization.)
- mortality.(60 days of randomization.)
- Length of hospital stay in days.(60 days of randomization.)
- Length of ICU stay in days.(60 days of randomization.)
Investigators
Montaser Gamal Ahmed
lecturer
Assiut University