Respiratory Failure, ICU
Conditions
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.
Interventions
OTHERprone 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.
Sponsors
Montaser Gamal Ahmed
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
Contacts
Primary ContactMontaser Gamal
Backup ContactAliae AR Mohamed Hussein
Outcome results
None listed