ARDS (Acute Respiratory Distress Syndrome)NCT07231107
Comparative Study Between Airway Pressure Release Ventilation and Pressure Regulated Volume Control (PRVC) in Protective Lung Strategy as a Recruitment Maneuver for Severe ARDS Mechanically Ventilated Patients Using Lung Ultrasound Score
A study testing Lung ultrasound in people with ARDS (Acute Respiratory Distress Syndrome), run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to elaborate on the effectiveness of recruitment maneuver by airway pressure release ventilation (APRV) as an open lung ventilatory strategy in comparison with PRVC mode in lung protective strategy regarding improvement of LUS score and P/F ratio in patients with severe ARDS Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Lung ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Aug 2022to 1 Jul 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-60 years old.
- Sex: both males and females
- Accepts health volunteers: No
- all Patients who were mechanically ventilated and diagnosed to have ARDS due to sepsis according to Berlin definition.
- During the course of the study, a new global definition for ARDS was introduced. To ensure our findings align with the most updated classification, we modified our inclusion criteria to incorporate the new global definition. Patients meeting the Berlin Definition or the new definition were included.
- Berlin Definition of the acute respiratory distress syndrome (ARDS) Acute Respiratory Distress Syndrome Timing Within 1 week of a known clinical insult or new or worsening respiratory Symptoms Chest imaging Bilateral opacities - not fully explained by effusion, lobar/lung collapse, or nodules. Origin of edema Respiratory failure not fully explained by cardiac failure or fluid overload need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present.
Show all 23Show fewer
- Oxygenation Mild 200 mmHg <Pao2/Fio2 < 300 mmHg with PEEP or CPAP > 5 cmH2O. Moderate 100 mmHg <Pao2/Fio2 < 200 mmHg with PEEP > 5 cmH2O. Severe Pao2/Fio2 < 100 mmHg with PEEP > 5 cmH2O. (Gordon D, et al; 2012). Diagnostic Criteria for the New Global Definition of ARDS Acute Respiratory Distress Syndrome Risk factors and origin of edema Precipitated by an acute predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock.
- Pulmonary edema is not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities are not primarily attributable to atelectasis. However, ARDS can be diagnosed in the presence of these conditions if a predisposing risk factor for ARDS is also present.
- Timing Acute onset or worsening of hypoxemic respiratory failure within 1 week of the estimated onset of the predisposing risk factor or new or worsening respiratory symptoms.
- Chest imaging Bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on ultrasound not fully explained by effusions, atelectasis, or nodules / masses.
- Oxygenation Non-intubated ARDS Intubated ARDS Modified Definition for Resource-Limited Settings
- PaO2:FIO2<300mmHg or
- SpO2:FIO2<315 (if SpO2<97%) on HFNO with flow of >30 L/min or NIV/CPAP with at least 5 cm H2O end-expiratory pressure Mild:
- 200<PaO2:FIO2<300 mm Hg Or
- 235<SpO2:FIO2<315 (if SpO2<97%)
- Moderate:
- 100, PaO2:FIO2<200 mm Hg or
- 148<SpO2:FIO2<235 (if SpO2<97%)
- Severe:
- PaO2:FIO2<100 mm Hg or
- SpO2:FIO2<148 (if SpO2<97%) • SpO2:FIO2<315 (if SpO2<97%).
- Neither positive end-expiratory pressure nor a minimum flow rate of oxygen is required for diagnosis in resource-limited settings.
- (Matthay MA, et al; 2024).
Who cannot join
- Patient refusal
- Patient with advanced cardiac disorders (rheumatic or ischemic).
- Patients with COPD, pneumothorax, surgical emphysema.
- Patients with advanced liver or renal disorders
- Patients with advanced malignancy.
- Female patients during pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to elaborate on the effectiveness of recruitment maneuver by airway pressure release ventilation (APRV) as an open lung ventilatory strategy in comparison with PRVC mode in lung protective strategy regarding improvement of LUS score and P/F ratio in patients with severe ARDS
Read the detailed description
Acute Respiratory distress syndrome (ARDS) is the most severe form of acute lung injury (ALI) which still has high rates of morbidity and mortality. Mechanical ventilation is still the backbone of patient management. One of the newly developed and successfully used strategies in patients with ARDS is lung protective strategies (LPS). However, use of low tidal volumes during LPS may be associated with atelectasis due to decreased alveolar inflation.
In acute respiratory distress syndrome (ARDS) patients, a recruitment strategy combines recruitment maneuvers (RMs) and positive end-expiratory pressure (PEEP) to prevent atelectrauma. Recruitment maneuvers are a voluntary strategy for effecting a temporary increase in trans-pulmonary pressure (PL), which in turn should reopen those alveolar units that are either poorly aerated or not aerated at all. PEEP may decrease ventilator-induced lung injury (VILI) by keeping those lung regions open that may otherwise collapse The Open lung approach is another ventilatory strategy complementary with the concept of protective ventilation. Lachmann was the first who introduced the open lung concept combining a lung recruitment maneuver (RM) with a sufficient level of PEEP. Recruitment maneuvers minimize the impact of the two known VILI mediators: tidal over distension (i.e., alveoli that receive volume and pressure that exceed their elastic limit) and tidal recruitment (i.e., the repetitive opening and closing of atelectasis during mechanical breathing), Airway pressure release ventilation (APRV) is one of the newly introduced modes in ARDS management. It is a pressure-controlled mode that uses two levels of pressures with inverted ratio ventilation. Release of airway pressure during APRV simulates expiration while elevated baseline pressure improves oxygenation. One of the advantages of this mode is that it allows spontaneous breathing It is considered an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) who struggle for oxygenation. Compared to the classical ventilation, APRV has been shown to provide lower peak pressure, better oxygenation, less circulatory loss, and better gas exchange without deteriorating the hemodynamic condition of the ARDS patient. This mode is believed to help to achieve the target of opening consolidated lung areas (recruitment) and to prevent repeated opening-closing of alveoli (recruitment). However, there still needs to be more and more proof to support this hypothesis. Recently, it has been proposed that the early use of protective mechanical ventilation with APRV could be used preemptively to prevent the development of ARDS in high-risk patients Lung Ultrasound has favorable features to assess RM due to its high specificity and sensitivity to detect lung collapse together with its non-invasiveness, availability, and simple use at the bedside. Ultrasound also has the capability of providing a differential diagnosis between atelectasis and lung consolidation of other origin such as pneumonia. The bilateral distribution of consolidations, presence of static air bronchograms, images of tidal recruitment within consolidation and absence of a companion pleural effusion strongly support the diagnosis of atelectasis. Furthermore, retrospectively the disappearance of the lung consolidation pattern after a RM confirms the diagnosis Acute respiratory distress syndrome (ARDS) is a severe life-threatening lung reaction to various forms of injuries that cause hypoxia. it has been demonstrated that mechanical ventilation by lung protection strategy can be provided in patients with ARDS, resulting in better pulmonary function and higher rates of weaning from the ventilator. lung-protective strategy was associated with improved survival in 28 days and a lower rate of barotrauma in patients with acute respiratory distress syndrome. Protective ventilation was not associated with a higher rate of survival to hospital discharge.
- Being tested
- Lung ultrasound
- Keywords
- Lung ultrasound, APRV, recruitment
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundProcedure or surgery
bedside lung ultrasound in six lung regions of interest, delineated by a parasternal line, anterior axillary line, posterior axillary line, and paravertebral line, are examined on each side. Each lung region is carefully examined in the longitudinal plane, and each intercostal space present in the region is examined in the transversal plane. The worst ultrasound pattern characterizes the region (regional LUS) using the following grading: 0 = normal aeration; 1 = moderate loss of aeration (interstitial syndrome, defined by multiple spaced B lines, or localized pulmonary edema, defined by coalescent B lines in less than 50% of the intercostal space examined in the transversal plane, or subpleural consolidations); 2 = severe loss of aeration (alveolar edema, defined by diffused coalescent B lines occupying the whole intercostal space); and 3 = complete loss of lung aeration (lung consolidation defined as a tissue pattern with or without air bronchogram)
| Study group | Role | What they receive |
|---|---|---|
| PRVC ventilated ARDS patients | Active comparator | managed by using conventional lung protective strategy using Pressure regulated volume control mode (PRVC) and positive end expiratory pressure, initial setting Tidal volume (VT):4-6ml/kg predicted body weight, PEEP according to ARDSnet guidelines recommendation for Low tidal volume high strategy. Receives: Procedure: Lung ultrasound |
| APRV ventilated ARDS patients | Active comparator | managed by airway pressure release ventilation mode initial settings Phigh:25 Plow:0 Thigh: 4.5 Tlow: 0.5 Fio2: 1. Options for setting the Phigh either premeasured Pplat or according to the Oxygenation index. Receives: Procedure: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound score
assessment of the lung interstitial tissue by ultrasound Ultrasound patterns at different degrees of lung aeration.
- Normal lung ultrasound pattern (score = 0).
- Well-Spaced B lines (moderate loss of aeration; score = 1).
- Coalescent B lines (severe loss of aeration; score = 2).
- Consolidated lung (complete loss of aeration; score = 3).
Measured: 7 days started after mechanical ventilation
P/F Ratio (Pao2/Fio2 Ratio)
ratio between the Partial pressure of Oxygen and the fraction of inspired oxygen Mild ARDS: 200 mmHg <Pao2/Fio2 < 300 mmHg Moderate ARDS:100 mmHg <Pao2/Fio2 < 200 mmHg Severe ARDS: Pao2/Fio2 < 100 mmHg
Measured: 7 days started after mechanical ventilation
Secondary outcomes (8)
Heart rate. (BPM).
heart rate in beat per minute
Measured: every 24 hours for 7 days after mechanical ventilation
Invasive Mean arterial blood pressure. (mmHG).
mean arterial blood pressure in mmHg
Measured: every 24 hours for 7 days after mechanical ventilation
Vasopressor-Inotrope score (VIS)
Vasopressor dose monitored daily using Vasopressor-Inotrope score (VIS) calculated as: Vasoactive-Inotropic Score = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x adrenaline dose (µg/ kg/ min) + 100 x noradrenaline dose (µg/kg/min) + 10 x milrinone dose (µg/kg/min) + 10.000 x vasopressin dose (U/kg/min)
Measured: every 24 hours for 7 days after mechanical ventilation
Lung compliance. (mL/cmH2O).
Lung compliance. (mL/cmH2O) calculated as change in tidal volume divided by the change in ventilating pressures
Measured: every 24 hours for 7 days after mechanical ventilation
Oxygenation index
Oxygenation index calculated as: mean airway pressure *Fio2*100) /Pao2
Measured: every 24 hours for 7 days after mechanical ventilation
Length of stay. (Days)
total Length of stay through study completion, From date of admission until the date of discharge or transfer or date of death from any cause, whichever came first, assessed up to 1 month
Measured: through study completion, From date of admission until the date of discharge or transfer or date of death from any cause, whichever came first, assessed up to 1 month
Total ventilation days
calculated from date of endotracheal intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 1 month
Measured: calculated From date of endotracheal intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 1 month
outcome
final outcome of the patient dicharged or improved, transferred or died
Measured: through study completion, From date of admission until the date of discharge or transfer or date of death from any cause, whichever came first, assessed up to 1 month"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start18 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shaban, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231107
- Sponsor's protocol ID
- FMASU MD 190/2022
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Matthay MA, Arabi Y, Arroliga AC, Bernard G, Bersten AD, Brochard LJ, Calfee CS, Combes A, Daniel BM, Ferguson ND, Gong MN, Gotts JE, Herridge MS, Laffey JG, Liu KD, Machado FR, Martin TR, McAuley DF, Mercat A, Moss M, Mularski RA, Pesenti A, Qiu H, Ramakrishnan N, Ranieri VM, Riviello ED, Rubin E, Slutsky AS, Thompson BT, Twagirumugabe T, Ware LB, Wick KD. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47. doi: 10.1164/rccm.202303-0558WS.
PubMed 37487152Habashi NM. Other approaches to open-lung ventilation: airway pressure release ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S228-40. doi: 10.1097/01.ccm.0000155920.11893.37.
PubMed 15753733Kucuk MP, Ozturk CE, Ilkaya NK, Kucuk AO, Ergul DF, Ulger F. The effect of preemptive airway pressure release ventilation on patients with high risk for acute respiratory distress syndrome: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):29-36. doi: 10.1016/j.bjane.2021.03.022. Epub 2021 Apr 24.
PubMed 33905798Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. doi: 10.1164/rccm.200506-976OC. Epub 2006 May 11.
PubMed 16690982
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Airway Pressure Release Ventilation and Pressure Regulated Volume Control (PRVC) in Protective Lung Strategy as a Recruitment Maneuver for Severe ARDS Mechanically Ventilated Patients Using Lung Ultrasound Score
- ClinicalTrials.gov ID
- NCT07231107
- Acronym / sponsor ID
- FMASU MD 190/2022
- Keywords
- Lung ultrasound, APRV, recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 17 Nov 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.
The aim of this study is to elaborate on the effectiveness of recruitment maneuver by airway pressure release ventilation (APRV) as an open lung ventilatory strategy in comparison with PRVC mode in lung protective strategy regarding improvement of LUS score and P/F ratio in patients with severe ARDS
Detailed description
Acute Respiratory distress syndrome (ARDS) is the most severe form of acute lung injury (ALI) which still has high rates of morbidity and mortality. Mechanical ventilation is still the backbone of patient management. One of the newly developed and successfully used strategies in patients with ARDS is lung protective strategies (LPS). However, use of low tidal volumes during LPS may be associated with atelectasis due to decreased alveolar inflation.
In acute respiratory distress syndrome (ARDS) patients, a recruitment strategy combines recruitment maneuvers (RMs) and positive end-expiratory pressure (PEEP) to prevent atelectrauma. Recruitment maneuvers are a voluntary strategy for effecting a temporary increase in trans-pulmonary pressure (PL), which in turn should reopen those alveolar units that are either poorly aerated or not aerated at all. PEEP may decrease ventilator-induced lung injury (VILI) by keeping those lung regions open that may otherwise collapse The Open lung approach is another ventilatory strategy complementary with the concept of protective ventilation. Lachmann was the first who introduced the open lung concept combining a lung recruitment maneuver (RM) with a sufficient level of PEEP. Recruitment maneuvers minimize the impact of the two known VILI mediators: tidal over distension (i.e., alveoli that receive volume and pressure that exceed their elastic limit) and tidal recruitment (i.e., the repetitive opening and closing of atelectasis during mechanical breathing), Airway pressure release ventilation (APRV) is one of the newly introduced modes in ARDS management. It is a pressure-controlled mode that uses two levels of pressures with inverted ratio ventilation. Release of airway pressure during APRV simulates expiration while elevated baseline pressure improves oxygenation. One of the advantages of this mode is that it allows spontaneous breathing It is considered an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) who struggle for oxygenation. Compared to the classical ventilation, APRV has been shown to provide lower peak pressure, better oxygenation, less circulatory loss, and better gas exchange without deteriorating the hemodynamic condition of the ARDS patient. This mode is believed to help to achieve the target of opening consolidated lung areas (recruitment) and to prevent repeated opening-closing of alveoli (recruitment). However, there still needs to be more and more proof to support this hypothesis. Recently, it has been proposed that the early use of protective mechanical ventilation with APRV could be used preemptively to prevent the development of ARDS in high-risk patients Lung Ultrasound has favorable features to assess RM due to its high specificity and sensitivity to detect lung collapse together with its non-invasiveness, availability, and simple use at the bedside. Ultrasound also has the capability of providing a differential diagnosis between atelectasis and lung consolidation of other origin such as pneumonia. The bilateral distribution of consolidations, presence of static air bronchograms, images of tidal recruitment within consolidation and absence of a companion pleural effusion strongly support the diagnosis of atelectasis. Furthermore, retrospectively the disappearance of the lung consolidation pattern after a RM confirms the diagnosis Acute respiratory distress syndrome (ARDS) is a severe life-threatening lung reaction to various forms of injuries that cause hypoxia. it has been demonstrated that mechanical ventilation by lung protection strategy can be provided in patients with ARDS, resulting in better pulmonary function and higher rates of weaning from the ventilator. lung-protective strategy was associated with improved survival in 28 days and a lower rate of barotrauma in patients with acute respiratory distress syndrome. Protective ventilation was not associated with a higher rate of survival to hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRVC ventilated ARDS patients | Active comparator | Procedure: Lung ultrasoundmanaged by using conventional lung protective strategy using Pressure regulated volume control mode (PRVC) and positive end expiratory pressure, initial setting Tidal volume (VT):4-6ml/kg predicted body weight, PEEP according to ARDSnet guidelines recommendation for Low tidal volume high strategy. |
| APRV ventilated ARDS patients | Active comparator | Procedure: Lung ultrasoundmanaged by airway pressure release ventilation mode initial settings Phigh:25 Plow:0 Thigh: 4.5 Tlow: 0.5 Fio2: 1. Options for setting the Phigh either premeasured Pplat or according to the Oxygenation index. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Age between 18-60 years old.
- Sex: both males and females
- Accepts health volunteers: No
- all Patients who were mechanically ventilated and diagnosed to have ARDS due to sepsis according to Berlin definition.
- During the course of the study, a new global definition for ARDS was introduced. To ensure our findings align with the most updated classification, we modified our inclusion criteria to incorporate the new global definition. Patients meeting the Berlin Definition or the new definition were included.
Key exclusion criteria (6 listed)
- Patient refusal
- Patient with advanced cardiac disorders (rheumatic or ischemic).
- Patients with COPD, pneumothorax, surgical emphysema.
- Patients with advanced liver or renal disorders
- Patients with advanced malignancy.
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 |
|---|---|---|
| Lung ultrasoundbedside lung ultrasound in six lung regions of interest, delineated by a parasternal line, anterior axillary line, posterior axillary line, and paravertebral line, are examined on each side. Each lung region is carefully examined in the longitudinal plane, and each intercostal space present in the region is examined in the transversal plane. The worst ultrasound pattern characterizes the region (regional LUS) using the following grading: 0 = normal aeration; 1 = moderate loss of aeration (interstitial syndrome, defined by multiple spaced B lines, or localized pulmonary edema, defined by coalescent B lines in less than 50% of the intercostal space examined in the transversal plane, or subpleural consolidations); 2 = severe loss of aeration (alveolar edema, defined by diffused coalescent B lines occupying the whole intercostal space); and 3 = complete loss of lung aeration (lung consolidation defined as a tissue pattern with or without air bronchogram) | Procedure or surgery | APRV ventilated ARDS patients, PRVC ventilated ARDS patients |
Primary outcome
lung ultrasound score
Time frame: 7 days started after mechanical ventilation
assessment of the lung interstitial tissue by ultrasound Ultrasound patterns at different degrees of lung aeration. 1. Normal lung ultrasound pattern (score = 0). 2. Well-Spaced B lines (moderate loss of aeration; score = 1). 3. Coalescent B lines (severe loss of aeration; score = 2). 4. Consolidated lung (complete loss of aeration; score = 3).
P/F Ratio (Pao2/Fio2 Ratio)
Time frame: 7 days started after mechanical ventilation
ratio between the Partial pressure of Oxygen and the fraction of inspired oxygen Mild ARDS: 200 mmHg <Pao2/Fio2 < 300 mmHg Moderate ARDS:100 mmHg <Pao2/Fio2 < 200 mmHg Severe ARDS: Pao2/Fio2 < 100 mmHg
8 secondary outcomes
Heart rate. (BPM).
Time frame: every 24 hours for 7 days after mechanical ventilation
Invasive Mean arterial blood pressure. (mmHG).
Time frame: every 24 hours for 7 days after mechanical ventilation
Vasopressor-Inotrope score (VIS)
Time frame: every 24 hours for 7 days after mechanical ventilation
Lung compliance. (mL/cmH2O).
Time frame: every 24 hours for 7 days after mechanical ventilation
Oxygenation index
Time frame: every 24 hours for 7 days after mechanical ventilation
Length of stay. (Days)
Time frame: through study completion, From date of admission until the date of discharge or transfer or date of death from any cause, whichever came first, assessed up to 1 month
Total ventilation days
Time frame: calculated From date of endotracheal intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 1 month
outcome
Time frame: through study completion, From date of admission until the date of discharge or transfer or date of death from any cause, whichever came first, assessed up to 1 month"
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 Dec 2025.
- Results publication: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Results publication: PubMed 37487152Matthay MA, Arabi Y, Arroliga AC, Bernard G, Bersten AD, Brochard LJ, Calfee CS, Combes A, Daniel BM, Ferguson ND, Gong MN, Gotts JE, Herridge MS, Laffey JG, Liu KD, Machado FR, Martin TR, McAuley DF, Mercat A, Moss M, Mularski RA, Pesenti A, Qiu H, Ramakrishnan N, Ranieri VM, Riviello ED, Rubin E, Slutsky AS, Thompson BT, Twagirumugabe T, Ware LB, Wick KD. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47. doi: 10.1164/rccm.202303-0558WS.
- Results publication: PubMed 15753733Habashi NM. Other approaches to open-lung ventilation: airway pressure release ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S228-40. doi: 10.1097/01.ccm.0000155920.11893.37.
- Results publication: PubMed 33905798Kucuk MP, Ozturk CE, Ilkaya NK, Kucuk AO, Ergul DF, Ulger F. The effect of preemptive airway pressure release ventilation on patients with high risk for acute respiratory distress syndrome: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):29-36. doi: 10.1016/j.bjane.2021.03.022. Epub 2021 Apr 24.
- Results publication: PubMed 16690982Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. doi: 10.1164/rccm.200506-976OC. Epub 2006 May 11.
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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 Lung ultrasound in people with ARDS (Acute Respiratory Distress Syndrome), run by Ain Shams University 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 23 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 3 Dec 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 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?
lung ultrasound score (time frame: 7 days started after mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07231107, which also lists 5 linked publications.
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 Dec 2025.