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

NCT ID: NCT07133022

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-04-30

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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Prone Positioning Protocol

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.

Group Type: EXPERIMENTAL

Early Prone Positioning Protocol

Intervention Type: 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.

Standard Care

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.

Group Type: ACTIVE_COMPARATOR

Standard ICU Care

Intervention Type: 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.

Interventions

Early Prone Positioning Protocol

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.

Intervention Type: PROCEDURE

Standard ICU Care

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.

Intervention Type: OTHER

Other Intervention Names

Prone Positioning for ARDS; Usual ARDS Management

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loai Muawiah Zabin

OTHER

Sponsor Role: lead

Responsible Party

Loai Muawiah Zabin

Assistant Professor, Faculty of Nursing

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sajed Ghawadra, PhD

Role: STUDY_CHAIR

Arab American University (Palestine)

Locations

Jenin Governmental Hospital

Jenin, , Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

R-2024/B/84/N

Identifier Type: OTHER

Identifier Source: secondary_id

AAUP-ARDS-2024

Identifier Type: -

Identifier Source: org_study_id