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

NCT07133022 | Completed

• 2 other identifiers: AAUP-ARDS-2024R-2024/B/84/N
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prone positioning; Non-invasive ventilation; Oxygenation; Intensive care unit; Early prone protocol; Low-resource settings; ARDS management; Clinical outcomes; Non-intubated ARDS; Critical care nursing; Quasi-experimental study; Palestine; Spontaneous breathing; ICU protocols

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in peripheral oxygen saturation (SpO₂ in %)

  Baseline, 2 hours, and 4 hours after intervention

• Change in respiratory rate (breaths/minute)

  Baseline, 2 hours, and 4 hours after intervention

• Change in serum bicarbonate (HCO₃ in mmol/L)

  Baseline, 2 hours, and 4 hours after intervention

• Change in arterial carbon dioxide pressure (PaCO₂ in mmHg)

  Baseline, 2 hours, and 4 hours after intervention

• Change in blood pH

  Baseline, 2 hours, and 4 hours after intervention

Study Arms (2)

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.

Procedure: Early Prone Positioning Protocol

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.

Other: Standard ICU Care

Interventions

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.

Also known as: Prone Positioning for ARDS

Early Prone Positioning Protocol

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.

Also known as: Usual ARDS Management

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loai Muawiah Zabin: lead

Study Sites (1)

Jenin Governmental Hospital

Jenin, 00970, Palestinian Territories

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypoxia; Respiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sajed Ghawadra, PhD

  Arab American University (Palestine)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None. Due to the physical nature of the intervention (prone positioning), blinding was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Faculty of Nursing

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 20, 2025
• Study Start: January 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)