Clinical trial NCT05698004: A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
Official title: A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure, ICU
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants within intervention arm whom need endotracheal intubation.
timeFrame: 30 days of randomization.
Secondary outcomes:
measure: Number of days on a ventilator.
timeFrame: 30 days of randomization.
measure: mortality.
timeFrame: 60 days of randomization.
measure: Length of ICU stay in days.
timeFrame: 60 days of randomization.
measure: Length of hospital stay in days.
timeFrame: 60 days of randomization.
Other outcomes:
Locations:
Study officials:
affiliation: Assuit university hospital
name: Sahar Refaat Mahmoud
role: PRINCIPAL_INVESTIGATOR
affiliation: Assuit university hospital
name: Sarah Mohamed Hashem Hamza.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assuit university hospital
name: Emad Zareef
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
citation: Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
citation: Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.