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

August 19, 2025 updated by: Loai Muawiah Zabin

Effectiveness of Early Prone Positioning on Clinical Outcomes in Non-intubated Acute Respiratory Distress Syndrome (ARDS) Patients: A Quasi-experimental Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: 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.
Other Names:
  • Prone Positioning for ARDS
Active Comparator: 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.
Other: 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.
Other Names:
  • Usual ARDS Management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in arterial oxygenation (PaO₂ in mmHg)
Time Frame: 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.
Baseline, 2 hours, and 4 hours after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in peripheral oxygen saturation (SpO₂ in %)
Time Frame: 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.
Baseline, 2 hours, and 4 hours after intervention
Change in respiratory rate (breaths/minute)
Time Frame: 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.
Baseline, 2 hours, and 4 hours after intervention
Change in serum bicarbonate (HCO₃ in mmol/L)
Time Frame: Baseline, 2 hours, and 4 hours after intervention
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)
Time Frame: 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.
Baseline, 2 hours, and 4 hours after intervention
Change in blood pH
Time Frame: Baseline, 2 hours, and 4 hours after intervention
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
Time Frame: Baseline, 2 hours, and 4 hours after intervention
Number of patients experiencing predefined complications (apnea, vomiting, discomfort, facial edema, decubitus ulcers) during ICU stay.
Baseline, 2 hours, and 4 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loai Muawiah Zabin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sajed Ghawadra, PhD, Arab American University (Palestine)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAUP-ARDS-2024
  • R-2024/B/84/N (Other Identifier: Institutional Review Board (IRB) at Arab American University-Palestine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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