A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group-1: prone positioning + standard treatment 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
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.
|
| No Intervention: Group-2: Standard treatment only 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 ICU stay in days. [60 days of randomization.]
duration of ICU stay from time of admission till discharge from ICU in days.
- Length of hospital stay in days. [60 days of randomization.]
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Montaser Gamal Ahmed
Investigators
- Principal Investigator: Sahar Refaat Mahmoud, Assuit university hospital
- Principal Investigator: Sarah Mohamed Hashem Hamza., Assuit university hospital
- Principal Investigator: Emad Zareef, Assuit university hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
- 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.
- 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.
- prone positioning in ICU