ARDS (Acute Respiratory Distress Syndrome)NCT07803614
Pressure Release Ventilation Compared to Lung Protective Ventilation in Moderate and Severe ARDS
A study testing Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV) in people with ARDS (Acute Respiratory Distress Syndrome), run by Koot Ahmad at 1 site in Egypt.
Trial summary
This study compares two different ways of providing mechanical ventilation to patients with moderate to severe acute respiratory distress syndrome (ARDS), a serious condition in which the lungs become inflamed and make it difficult to breathe and maintain normal oxygen levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2025to 21 Aug 2026
- 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
- Adult patients aged 18 years or older.
- Mechanically ventilated patients admitted to the Intensive Care Unit (ICU) at Banha University Hospital.
- Patients diagnosed with moderate-to-severe acute respiratory distress syndrome (ARDS) according to the 2023 European Society of Intensive Care Medicine (ESICM) guidelines, characterized by (Matthay et al., 2024):
- An acute predisposing risk factor (e.g., pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock), with pulmonary edema not primarily attributable to cardiogenic causes or fluid overload.
- Acute onset or worsening of hypoxemic respiratory failure within one week of the onset of the predisposing risk factor or new/worsening respiratory symptoms.
- Bilateral pulmonary opacities on chest radiography, computed tomography, or lung ultrasound that are not fully explained by pleural effusions, atelectasis, or pulmonary nodules/masses.
- Moderate ARDS defined as a PaO₂/FiO₂ ratio >100 to ≤200 mmHg (or SpO₂/FiO₂ ratio >148 to ≤235 when SpO₂ <97%) or severe ARDS defined as a PaO₂/FiO₂ ratio ≤100 mmHg (or SpO₂/FiO₂ ratio ≤148).
Who cannot join
- Patients younger than 18 years of age.
- Pregnant women.
- Patients with severe chronic heart failure (New York Heart Association Class III or IV).
- Patients with uncontrolled shock requiring escalating doses of vasopressor support.
- Patients with severe cardiac arrhythmias or active myocardial ischemia.
Trial locations and contacts
1 site in 1 country.
About this study
This study compares two different ways of providing mechanical ventilation to patients with moderate to severe acute respiratory distress syndrome (ARDS), a serious condition in which the lungs become inflamed and make it difficult to breathe and maintain normal oxygen levels. Patients are randomly assigned to receive either airway pressure release ventilation (APRV) or conventional low-tidal-volume ventilation (LTV). The study compares the two ventilation strategies in terms of successful removal from the ventilator, time needed on mechanical ventilation, improvement in blood oxygen levels, length of stay in the intensive care unit and hospital, and complications such as the need for reintubation, barotrauma, and death. The aim is to determine whether APRV provides better outcomes than conventional low-tidal-volume ventilation in patients with moderate to severe ARDS.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure characterized by impaired oxygenation and bilateral pulmonary abnormalities. Mechanical ventilation is a cornerstone of supportive treatment for patients with moderate to severe ARDS.
This prospective randomized controlled study compares airway pressure release ventilation (APRV) with conventional low-tidal-volume ventilation (LTV) in patients with moderate to severe ARDS. Eligible patients are randomly allocated in a 1:1 ratio to receive either APRV or LTV according to a predefined ventilation protocol.
In the LTV group, ventilation is provided using a lung-protective strategy with tidal volumes targeted according to predicted body weight and limitation of plateau pressure. In the APRV group, ventilation is delivered using two airway pressure levels with prolonged high-pressure periods and brief release periods. APRV settings are individualized according to oxygenation, ventilation, respiratory mechanics, clinical response, and hemodynamic tolerance. Release tidal volume, minute ventilation, and respiratory-system compliance are monitored during APRV.
Patients in both groups undergo daily assessment for readiness for ventilator weaning. Once predefined weaning criteria are met, patients undergo a standardized spontaneous breathing trial using the same procedure in both groups. Patients who successfully complete the trial are assessed for extubation according to predefined clinical criteria.
The primary outcome is successful extubation, defined as liberation from invasive mechanical ventilation without the need for reintubation within 72 hours after extubation. Secondary outcomes include time to successful extubation, duration of mechanical ventilation, change in the PaO₂/FiO₂ ratio during the first 7 days, ICU length of stay, and hospital length of stay. Safety outcomes include all-cause mortality and barotrauma.
- Being tested
- Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV)
- Keywords
- Acute respiratory distress syndrome, Airway pressure release ventilation (APRV), Low-tidal-volume ventilation (LTV), Acute respiratory failure, Extubation, Oxygenation
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV)Behavioural
For LTV
Participants received conventional low-tidal-volume mechanical ventilation using a tidal volume of 4-8 mL/kg predicted body weight, with plateau pressure maintained below 30 cmH₂O. Ventilator settings were adjusted according to oxygenation, ventilation, respiratory mechanics, and hemodynamic status. FiO₂ and PEEP were adjusted to maintain the predefined oxygenation target. Patients underwent the standardized weaning and spontaneous breathing trial protocol used in both study groups.
For APRV
Participants received airway pressure release ventilation using two airway pressure levels (P-high and P-low), prolonged T-high, and brief T-low periods. P-high was initially set at 20-30 cmH₂O and P-low at 5 cmH₂O. T-high was initially set at 4-6 seconds and T-low at 0.6 seconds, with T-low subsequently adjusted according to the expiratory-flow waveform to limit excessive expiratory lung emptying and maintain end-expiratory lung volume. FiO₂ was adjusted to maintain SpO₂ at 88-95%. Rele
| Study group | Role | What they receive |
|---|---|---|
| Low-Tidal-Volume Ventilation (LTV) | Active comparator | Participants assigned to the LTV group received conventional lung-protective mechanical ventilation using a tidal volume of 4-8 mL/kg predicted body weight, with adjustment according to respiratory mechanics and clinical response. Plateau pressure was maintained below 30 cmH₂O. Ventilator settings were adjusted according to oxygenation, ventilation, respiratory mechanics, and hemodynamic status. Receives: Behavioral: Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV) |
| Airway Pressure Release Ventilation (APRV) | Experimental | Participants assigned to the APRV group received airway pressure release ventilation using two airway pressure levels, prolonged T-high, and brief T-low periods. P-high was initially set at 20-30 cmH₂O and subsequently adjusted according to oxygenation and respiratory mechanics. P-low was set at 5 cmH₂O. T-high was initially set at 4-6 seconds, while T-low was initially set at 0.6 seconds and subsequently adjusted according to the expiratory-flow waveform to limit excessive expiratory lung emptying and maintain end-expiratory lung volume. FiO₂ was adjusted to maintain SpO₂ at 88-95%. Release tidal volume, minute ventilation, and static respiratory-system compliance were monitored. Receives: Behavioral: Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful extubation
Liberation from invasive mechanical ventilation without the need for reintubation within 72 hours after extubation.
Measured: From randomization until 72 hours after extubation
Secondary outcomes (4)
Time to successful extubation
Time from randomization to successful extubation among patients who achieved successful extubation, defined as liberation from invasive mechanical ventilation followed by at least 72 hours without reintubation.
Measured: From randomization until successful extubation, hospital discharge, or death, whichever occurred first; assessed up to 30 days.
Change in PaO₂/FiO₂ ratio
Change in the PaO₂/FiO₂ ratio from baseline to 1, 3, and 7 days after initiation of the assigned ventilatory strategy (LTV or APRV).
Measured: At baseline and 1, 3, and 7 days after initiation of the assigned ventilatory strategy.
ICU length of stay
Duration of stay in the intensive care unit, calculated from ICU admission until ICU discharge or death, whichever occurred first.
Measured: From ICU admission until ICU discharge or death, whichever occurred first, assessed up to 30 days.
Hospital length of stay
Total duration of hospitalization, calculated from hospital admission until hospital discharge or death, whichever occurred first.
Measured: From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start30 Apr 2025
- Primary completion20 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel ventilation strategies: airway pressure release ventilation (APRV) or conventional low-tidal-volume ventilation (LTV). Participants remained in their assigned group throughout the study, and outcomes were compared between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koot Ahmad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Koot Ahmad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803614
- Sponsor's protocol ID
- ms 24-5-2025
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported study results will be shared, including demographic and baseline clinical characteristics, ventilation parameters, arterial blood gas and oxygenation measurements, duration of mechanical ventilation, extubation outcomes, reintubation, ICU and hospital length of stay, and reported safety outcomes including mortality and barotrauma. Direct personal identifiers will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Release Ventilation Compared to Lung Protective Ventilation in Moderate and Severe ARDS
- ClinicalTrials.gov ID
- NCT07803614
- Acronym / sponsor ID
- ms 24-5-2025
- Keywords
- Acute respiratory distress syndrome, Airway pressure release ventilation (APRV), Low-tidal-volume ventilation (LTV), Acute respiratory failure, Extubation, Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Koot AhmadUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 3 Sep 2026 (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 compares two different ways of providing mechanical ventilation to patients with moderate to severe acute respiratory distress syndrome (ARDS), a serious condition in which the lungs become inflamed and make it difficult to breathe and maintain normal oxygen levels. Patients are randomly assigned to receive either airway pressure release ventilation (APRV) or conventional low-tidal-volume ventilation (LTV). The study compares the two ventilation strategies in terms of successful removal from the ventilator, time needed on mechanical ventilation, improvement in blood oxygen levels, length of stay in the intensive care unit and hospital, and complications such as the need for reintubation, barotrauma, and death. The aim is to determine whether APRV provides better outcomes than conventional low-tidal-volume ventilation in patients with moderate to severe ARDS.
Detailed description
Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure characterized by impaired oxygenation and bilateral pulmonary abnormalities. Mechanical ventilation is a cornerstone of supportive treatment for patients with moderate to severe ARDS.
This prospective randomized controlled study compares airway pressure release ventilation (APRV) with conventional low-tidal-volume ventilation (LTV) in patients with moderate to severe ARDS. Eligible patients are randomly allocated in a 1:1 ratio to receive either APRV or LTV according to a predefined ventilation protocol.
In the LTV group, ventilation is provided using a lung-protective strategy with tidal volumes targeted according to predicted body weight and limitation of plateau pressure. In the APRV group, ventilation is delivered using two airway pressure levels with prolonged high-pressure periods and brief release periods. APRV settings are individualized according to oxygenation, ventilation, respiratory mechanics, clinical response, and hemodynamic tolerance. Release tidal volume, minute ventilation, and respiratory-system compliance are monitored during APRV.
Patients in both groups undergo daily assessment for readiness for ventilator weaning. Once predefined weaning criteria are met, patients undergo a standardized spontaneous breathing trial using the same procedure in both groups. Patients who successfully complete the trial are assessed for extubation according to predefined clinical criteria.
The primary outcome is successful extubation, defined as liberation from invasive mechanical ventilation without the need for reintubation within 72 hours after extubation. Secondary outcomes include time to successful extubation, duration of mechanical ventilation, change in the PaO₂/FiO₂ ratio during the first 7 days, ICU length of stay, and hospital length of stay. Safety outcomes include all-cause mortality and barotrauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel ventilation strategies: airway pressure release ventilation (APRV) or conventional low-tidal-volume ventilation (LTV). Participants remained in their assigned group throughout the study, and outcomes were compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Low-Tidal-Volume Ventilation (LTV) | Active comparator | Behavioral: Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV)Participants assigned to the LTV group received conventional lung-protective mechanical ventilation using a tidal volume of 4-8 mL/kg predicted body weight, with adjustment according to respiratory mechanics and clinical response. Plateau pressure was maintained below 30 cmH₂O. Ventilator settings were adjusted according to oxygenation, ventilation, respiratory mechanics, and hemodynamic status. |
| Airway Pressure Release Ventilation (APRV) | Experimental | Behavioral: Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV)Participants assigned to the APRV group received airway pressure release ventilation using two airway pressure levels, prolonged T-high, and brief T-low periods. P-high was initially set at 20-30 cmH₂O and subsequently adjusted according to oxygenation and respiratory mechanics. P-low was set at 5 cmH₂O. T-high was initially set at 4-6 seconds, while T-low was initially set at 0.6 seconds and subsequently adjusted according to the expiratory-flow waveform to limit excessive expiratory lung emptying and maintain end-expiratory lung volume. FiO₂ was adjusted to maintain SpO₂ at 88-95%. Release tidal volume, minute ventilation, and static respiratory-system compliance were monitored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients aged 18 years or older.
- Mechanically ventilated patients admitted to the Intensive Care Unit (ICU) at Banha University Hospital.
- Patients diagnosed with moderate-to-severe acute respiratory distress syndrome (ARDS) according to the 2023 European Society of Intensive Care Medicine (ESICM) guidelines, characterized by (Matthay et al., 2024):
Key exclusion criteria (5 listed)
- Patients younger than 18 years of age.
- Pregnant women.
- Patients with severe chronic heart failure (New York Heart Association Class III or IV).
- Patients with uncontrolled shock requiring escalating doses of vasopressor support.
- Patients with severe cardiac arrhythmias or active myocardial ischemia.
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 |
|---|---|---|
| Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV)For LTV Participants received conventional low-tidal-volume mechanical ventilation using a tidal volume of 4-8 mL/kg predicted body weight, with plateau pressure maintained below 30 cmH₂O. Ventilator settings were adjusted according to oxygenation, ventilation, respiratory mechanics, and hemodynamic status. FiO₂ and PEEP were adjusted to maintain the predefined oxygenation target. Patients underwent the standardized weaning and spontaneous breathing trial protocol used in both study groups. For APRV Participants received airway pressure release ventilation using two airway pressure levels (P-high and P-low), prolonged T-high, and brief T-low periods. P-high was initially set at 20-30 cmH₂O and P-low at 5 cmH₂O. T-high was initially set at 4-6 seconds and T-low at 0.6 seconds, with T-low subsequently adjusted according to the expiratory-flow waveform to limit excessive expiratory lung emptying and maintain end-expiratory lung volume. FiO₂ was adjusted to maintain SpO₂ at 88-95%. Rele | Behavioural | Airway Pressure Release Ventilation (APRV), Low-Tidal-Volume Ventilation (LTV) |
Primary outcome
Successful extubation
Time frame: From randomization until 72 hours after extubation
Liberation from invasive mechanical ventilation without the need for reintubation within 72 hours after extubation.
4 secondary outcomes
Time to successful extubation
Time frame: From randomization until successful extubation, hospital discharge, or death, whichever occurred first; assessed up to 30 days.
Change in PaO₂/FiO₂ ratio
Time frame: At baseline and 1, 3, and 7 days after initiation of the assigned ventilatory strategy.
ICU length of stay
Time frame: From ICU admission until ICU discharge or death, whichever occurred first, assessed up to 30 days.
Hospital length of stay
Time frame: From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 30 days.
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 3 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported study results will be shared, including demographic and baseline clinical characteristics, ventilation parameters, arterial blood gas and oxygenation measurements, duration of mechanical ventilation, extubation outcomes, reintubation, ICU and hospital length of stay, and reported safety outcomes including mortality and barotrauma. Direct personal identifiers will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 Intervention Name: Low-Tidal-Volume Ventilation (LTV) in people with ARDS (Acute Respiratory Distress Syndrome), run by Koot Ahmad at 1 site in Egypt.
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 7 inclusion and 5 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 3 Sep 2026. 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 Egypt. 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?
Successful extubation (time frame: From randomization until 72 hours after extubation). 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 3 Sep 2026.