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

Not Applicable

Not yet recruiting

• Conditions: Respiratory Failure, ICU

• Registration Number: NCT05698004
• Lead Sponsor: Montaser Gamal Ahmed

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 Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2023-01-15
• Last Update Submitted: 2023-01-15
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Study Start: 2023-02-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 244

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants within intervention arm whom need endotracheal intubation.	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 Outcome Measures

Name	Time	Method
Number of days on a ventilator.	30 days of randomization.	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.
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.	duration of ICU stay from time of admission till discharge from ICU in days.