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| ID | Type | Description | Link |
|---|---|---|---|
| R-2024/B/84/N | Other Identifier | Institutional Review Board (IRB) at Arab American University-Palestine |
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This study aimed to evaluate the effectiveness of early prone positioning in improving clinical outcomes among non-intubated patients with Acute Respiratory Distress Syndrome (ARDS). Prone positioning, which involves placing patients on their stomachs, has been shown to improve outcomes in patients on mechanical ventilation. However, limited evidence exists for its use in non-intubated patients. The researchers conducted a quasi-experimental study at Jenin Governmental Hospital in Palestine, involving two groups: one received early prone positioning in addition to standard care, and the other received standard care alone. Key clinical outcomes included respiratory rate, oxygen saturation, need for intubation, length of Intensive Care Unit (ICU) stay, and mortality. This study adds to the growing evidence supporting non-invasive interventions for managing ARDS and may help inform future clinical guidelines in low-resource settings.
Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by rapid-onset respiratory failure, low blood oxygen levels (hypoxemia), and bilateral pulmonary infiltrates. While prone positioning has become an established part of care for intubated patients with moderate to severe ARDS, its role in non-intubated, spontaneously breathing patients remains underexplored, particularly in resource-limited settings.
This quasi-experimental study assessed the clinical effectiveness of early implementation of prone positioning in non-intubated ARDS patients in the Intensive Care Unit (ICU) of Jenin Governmental Hospital, Palestine. The study was conducted from January to April 2024. A total of 100 adult patients who met the Berlin definition of ARDS and did not require immediate intubation were enrolled and divided into two groups of 50: the intervention group received early prone positioning alongside standard medical care, while the control group received only standard care without prone positioning.
The primary clinical endpoints included changes in oxygen saturation (SpO₂), respiratory rate, need for mechanical ventilation, and length of ICU stay. Additional variables such as arterial blood gas (ABG) parameters, hemodynamic stability, and patient tolerance to prone positioning were monitored throughout the ICU admission. Patients were followed until ICU discharge or in-hospital mortality.
The early prone positioning protocol was implemented within 24 hours of ARDS diagnosis. Patients were assisted to maintain the prone position for multiple daily sessions, each lasting 2-4 hours, depending on tolerance and clinical stability. Standardized nursing assessments and physician evaluations were performed to monitor safety and efficacy.
Data were analyzed using appropriate statistical methods to compare outcomes between groups. Ethical approval was obtained from the Arab American University Institutional Review Board (IRB reference: R-2024/B/84/N). The study provides insight into the feasibility, safety, and potential clinical benefit of prone positioning as a low-cost, non-invasive intervention for managing ARDS in non-intubated patients, with implications for ICU protocols in low- and middle-income countries (LMICs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Prone Positioning Protocol | Experimental | Participants in this arm received early prone positioning as part of the study protocol. Patients were assisted into a prone position for 4 hours, with measurements taken at baseline, 2 hours, and 4 hours. The intervention was initiated soon after the Acute Respiratory Distress Syndrome (ARDS) diagnosis, according to clinical stability and eligibility. The procedure was supervised by trained Intensive Care Unit (ICU) nurses, with continuous monitoring for tolerance, oxygenation status, and safety. |
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| Standard Care | Active Comparator | Participants in this arm received standard Intensive Care Unit (ICU) care without early implementation of prone positioning. Any use of prone positioning occurred at the discretion of the treating medical team and was not based on a standardized protocol. All other supportive treatments followed routine ICU protocols. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Prone Positioning Protocol | Procedure | A structured protocol in which non-intubated patients with Acute Respiratory Distress Syndrome (ARDS) are positioned prone for 2-4 hours per session, multiple times per day, totaling approximately 8 hours daily for 5 consecutive days. Initiation begins within 24 hours of ARDS diagnosis. Administered by trained Intensive Care Unit (ICU) nurses under medical supervision. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial oxygenation (PaO₂ in mmHg) | This outcome assesses the effect of early prone positioning on arterial oxygenation in non-intubated Acute Respiratory Distress Syndrome (ARDS) patients. The partial pressure of arterial oxygen (PaO₂) will be measured via arterial blood gas (ABG) analysis and compared between the intervention and control groups. | Baseline, 2 hours, and 4 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral oxygen saturation (SpO₂ in %) | Peripheral capillary oxygen saturation (SpO₂) will be measured using pulse oximetry to evaluate changes in oxygen saturation between intervention and control groups. | Baseline, 2 hours, and 4 hours after intervention |
| Change in respiratory rate (breaths/minute) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sajed Ghawadra, PhD | Arab American University (Palestine) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jenin Governmental Hospital | Jenin | 00970 | Palestinian Territories |
Individual participant data (IPD) will not be shared due to institutional data protection policies, lack of dedicated infrastructure for secure data sharing, and the absence of participant consent for data sharing beyond the scope of the current study. Additionally, the study was conducted without external funding, which limits the capacity for data curation and repository access required for responsible sharing.
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Participants were assigned to either the intervention group receiving early prone positioning or the control group receiving standard care. The study followed a quasi-experimental, non-randomized parallel assignment model.
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None. Due to the physical nature of the intervention (prone positioning), blinding was not feasible.
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| Standard ICU Care | Other | Participants receive routine Intensive Care Unit (ICU) care for Acute Respiratory Distress Syndrome (ARDS) without the implementation of a structured early prone positioning protocol. Care is provided at the discretion of the treating physicians, following standard ICU management practices. |
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Respiratory rate will be recorded by direct observation and counted per minute to assess improvement in breathing pattern. |
| Baseline, 2 hours, and 4 hours after intervention |
| Change in serum bicarbonate (HCO₃ in mmol/L) | Bicarbonate (HCO₃) concentration will be obtained from arterial blood gas results to assess metabolic compensation. | Baseline, 2 hours, and 4 hours after intervention |
| Change in arterial carbon dioxide pressure (PaCO₂ in mmHg) | Partial pressure of arterial carbon dioxide (PaCO₂) will be measured using arterial blood gas analysis to evaluate ventilatory status. | Baseline, 2 hours, and 4 hours after intervention |
| Change in blood pH | Blood pH will be measured via arterial blood gas analysis to assess acid-base balance. | Baseline, 2 hours, and 4 hours after intervention |
| Incidence of complications | Number of patients experiencing predefined complications (apnea, vomiting, discomfort, facial edema, decubitus ulcers) during ICU stay. | Baseline, 2 hours, and 4 hours after intervention |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000860 | Hypoxia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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