Early Prone Positioning and Clinical Outcomes in Non-Intubated Acute Respiratory Distress Syndrome (ARDS) Patients

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome (ARDS); Hypoxemia; Respiratory Failure; Non-Intubated Patients; Intensive Care Unit ICU

• Registration Number: NCT07133022
• Lead Sponsor: Loai Muawiah Zabin

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Awake patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to established criteria.
• Eligible for prone positioning combined with non-invasive respiratory support.
• Willing and able to provide informed consent.
• Aged 18 years or older.
• Hemodynamically stable.
• Conscious, normal mental status, able to follow instructions, and capable of self-positioning.

Exclusion Criteria

• Severe hemodynamic instability or other contraindications to prone positioning.
• Inability to provide consent or participate actively.
• Significant comorbidities that could confound outcomes.
• Impaired consciousness or inability to change position.
• Normal oxygen saturation without supplemental oxygen.
• Respiratory fatigue or patients receiving end-of-life care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in arterial oxygenation (PaO₂ in mmHg)	Baseline, 2 hours, and 4 hours after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Change in peripheral oxygen saturation (SpO₂ in %)	Baseline, 2 hours, and 4 hours after intervention	Peripheral capillary oxygen saturation (SpO₂) will be measured using pulse oximetry to evaluate changes in oxygen saturation between intervention and control groups.
Change in respiratory rate (breaths/minute)	Baseline, 2 hours, and 4 hours after intervention	Respiratory rate will be recorded by direct observation and counted per minute to assess improvement in breathing pattern.
Change in serum bicarbonate (HCO₃ in mmol/L)	Baseline, 2 hours, and 4 hours after intervention	Bicarbonate (HCO₃) concentration will be obtained from arterial blood gas results to assess metabolic compensation.
Change in arterial carbon dioxide pressure (PaCO₂ in mmHg)	Baseline, 2 hours, and 4 hours after intervention	Partial pressure of arterial carbon dioxide (PaCO₂) will be measured using arterial blood gas analysis to evaluate ventilatory status.
Change in blood pH	Baseline, 2 hours, and 4 hours after intervention	Blood pH will be measured via arterial blood gas analysis to assess acid-base balance.
Incidence of complications	Baseline, 2 hours, and 4 hours after intervention	Number of patients experiencing predefined complications (apnea, vomiting, discomfort, facial edema, decubitus ulcers) during ICU stay.

Trial Locations

Locations (1)

Jenin Governmental Hospital; 🇵🇸 Jenin, Palestinian Territory, occupied