A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure

Conditions
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Respiratory Failure, ICU

Intervention / Treatment
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* Other: prone positioning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with acute hypoxemic respiratory failure attending the participating centres will receive either prone positioning + standard treatment or standard treatment only. All new acute hypoxemic respiratory failure patients will receive prone positioning + standard treatment for the first two weeks of the study. During the following two weeks, all new patients will receive standard treatment only. These cycles will be repeated until completion the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group-1: prone positioning + standard treatment<br>Patients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required. | Other: prone positioning<br>* The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU.<br>|
| No Intervention: Group-2: Standard treatment only<br>Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants within intervention arm whom need endotracheal intubation. | 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)). | 30 days of randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days on a ventilator. | weaning considered successful if patient is able to achieve the following within 48 hours: pH >7.35, Decrease in PaCO2 of >15-20%, PaO2>60 mmHg, SaO2> 90% on FiO2 <40%, Respiratory rate < 24 bpm and No signs of respiratory distress like agitation, diaphoresis or anxiety. | 30 days of randomization. | 
| mortality. |  | 60 days of randomization. | 
| Length of ICU stay in days. | duration of ICU stay from time of admission till discharge from ICU in days. | 60 days of randomization. | 
| Length of hospital stay in days. |  | 60 days of randomization. |