Acute Respiratory Distress Syndrome (ARDS)EPP-ARDSNCT07133022
Early Prone Positioning and Clinical Outcomes in Non-Intubated Acute Respiratory Distress Syndrome (ARDS) Patients
A study testing Early Prone Positioning Protocol and Standard ICU Care in people with Acute Respiratory Distress Syndrome (ARDS) and Hypoxemia, run by Loai Muawiah Zabin at 1 site in Palestinian Territories.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Hypoxemia, Respiratory Failure
- What is being tested?
- Early Prone Positioning Protocol and Standard ICU Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Jenin Governmental Hospital
Jenin, 00970
About this study
Official title: 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.
Read the 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
- Being tested
- Early Prone Positioning Protocol, Standard ICU Care
- 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
- Medical subject headings
- Respiratory Distress Syndrome, Hypoxia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Prone Positioning ProtocolProcedure or surgery
Also called Prone Positioning for ARDS
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 ICU CareOther
Also called Usual ARDS Management
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard ICU Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 hours, and 4 hours after intervention
Secondary outcomes (6)
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.
Measured: Baseline, 2 hours, and 4 hours after intervention
Change in respiratory rate (breaths/minute)
Respiratory rate will be recorded by direct observation and counted per minute to assess improvement in breathing pattern.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 hours, and 4 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loai Muawiah Zabin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loai Muawiah Zabin, Arab American University (Palestine)
- Investigators
- Sajed Ghawadra, PhD, Study chair, Arab American University (Palestine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133022
- Sponsor's protocol ID
- AAUP-ARDS-2024
- Other IDs
- R-2024/B/84/N
- Acronym
- EPP-ARDS
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Prone Positioning on Clinical Outcomes in Non-intubated Acute Respiratory Distress Syndrome (ARDS) Patients: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07133022
- Acronym / sponsor ID
- EPP-ARDS / AAUP-ARDS-2024
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Loai Muawiah ZabinUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Prone Positioning Protocol | Experimental | Procedure: Early Prone Positioning ProtocolParticipants 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. |
| Standard Care | Active comparator | Other: Standard ICU CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Prone Positioning ProtocolAlso: Prone Positioning for ARDSA 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. | Procedure or surgery | Early Prone Positioning Protocol |
| Standard ICU CareAlso: Usual ARDS ManagementParticipants 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 | Standard Care |
Primary outcome
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.
6 secondary outcomes
Change in peripheral oxygen saturation (SpO₂ in %)
Time frame: Baseline, 2 hours, and 4 hours after intervention
Change in respiratory rate (breaths/minute)
Time frame: 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
Change in arterial carbon dioxide pressure (PaCO₂ in mmHg)
Time frame: Baseline, 2 hours, and 4 hours after intervention
Change in blood pH
Time frame: Baseline, 2 hours, and 4 hours after intervention
Incidence of complications
Time frame: Baseline, 2 hours, and 4 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sajed Ghawadra, PhD study chair
Arab American University (Palestine)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Prone Positioning Protocol and Standard ICU Care in people with Acute Respiratory Distress Syndrome (ARDS) and Hypoxemia, run by Loai Muawiah Zabin at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial oxygenation (PaO₂ in mmHg) (time frame: Baseline, 2 hours, and 4 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.