Acute Respiratory Syndrome DistressPEEPNCT06733168
The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe ARDS
A study testing electrical impedance tomography and Non-EIT in people with Acute Respiratory Syndrome Distress and Positive End-Expiratory Pressure, run by Vietnam Military Medical University at 1 site in Vietnam.
Trial summary
Acute respiratory distress syndrome (ARDS) in its moderate to severe forms is associated with high mortality. Mechanical ventilation (MV) remains the cornerstone of ARDS management but carries a significant risk of ventilator-induced lung injury (VILI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Syndrome Distress, Positive End-Expiratory Pressure, Mechanical Ventilation
- What is being tested?
- electrical impedance tomography and Non-EIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Aug 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years.
- Intubated moderate and severe ARDS according to the New Global Definition (PaO2/FiO2 ≤200 mmHg).
- Used continuous sedation with or without paralysis.
Who cannot join
- Presence of pneumothorax that is either undrained or newly occurred.
- Unstable hemodynamics with a mean arterial pressure < 60 mmHg and unresponsive to resuscitation measures, and/or heart rate < 60 bpm.
- Contraindications for EIT (pacemakers, automatic external defibrillators, cases of chest trauma or recent chest surgery limiting EIT belt application).
- Pregnancy.
- Severe neuromuscular disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Intensive Care Center, Bach Mai Hospital
Hanoi
Son Ngoc Do, Prof. PhD. MD, (+84) 914669880, sonngocdo@gmail.com
About this study
Acute respiratory distress syndrome (ARDS) in its moderate to severe forms is associated with high mortality. Mechanical ventilation (MV) remains the cornerstone of ARDS management but carries a significant risk of ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP), a fundamental component of MV, is widely utilized in clinical practice; however, optimal PEEP selection for patients with moderate to severe ARDS remains a complex and unresolved challenge. Electrical impedance tomography (EIT), a bedside imaging modality that evaluates regional ventilation distribution, offers a means of individualizing PEEP settings in mechanically ventilated patients. By balancing the competing risks of alveolar overdistension and collapse, EIT facilitates precision in PEEP titration. This study compares the impact of EIT-guided PEEP selection versus the conventional low FiO2-PEEP table on blood oxygenation and pulmonary mechanics.
Read the detailed description
This is a prospective, single-center, randomized controlled trial designed to evaluate the effects of PEEP settings guided by electrical impedance tomography (EIT) on clinical outcomes in patients with moderate to severe ARDS undergoing lung-protective ventilation. Adult intubated patients with moderate to severe ARDS will be enrolled in the study.
Patients in the intervention group will receive PEEP titrated using EIT with a stepwise decremental PEEP trial, while those in the control group will have PEEP set based on the FiO2-PEEP table. Other ventilator parameters will be managed according to the ARDSnet protocol.
The primary outcomes are blood oxygenation and pulmonary mechanics. Secondary outcomes include 28-day mortality, ventilator-free and shock-free days at 28 days, length of ICU and hospital stay, rate of successful weaning, the proportion requiring rescue therapies, complications, respiratory variables, and the Sequential Organ Failure Assessment (SOFA) score.
Before initiating recruitment maneuver, all patients were placed on mechanical ventilation set according to the ARDS network strategy for 10 minutes, ensuring SpO2 of 88-95%, PaO2 of 55-80 mmHg, and a mean arterial pressure (MAP) ≥ 65 mmHg.
- Patients received sedation and neuromuscular blockade to achieve full synchronization with the ventilator (RASS ≤ -3).
- The mode was set to Pressure-Controlled Ventilation (PCV): ΔP = 15 cmH2O, which was maintained constant during the recruitment maneuver, while FiO2, PEEP, and respiratory rate were kept as previously set.
- PEEP was incrementally increased by 5 cmH2O every minute: from 10 to 15, to 20, and finally to 25 cmH2O, with a maximum pressure limit of 40 cmH2O.
- Following the recruitment maneuver at the final PEEP level, the process of identifying the optimal PEEP was initiated.
- Then, PEEP will be set to 20 cmH2O and gradually decreased by 2 cmH2O every 30 seconds until it reached 6 cmH2O or SpO2 dropped to ≤ 80%.
- Selection of optimal PEEP: The optimal PEEP was defined as the intersection point between the alveolar overdistension and collapse curves as measured by the EIT system.
- Termination Criteria: If persistent hypotension (mean arterial pressure decrease > 15 mmHg) or sustained hypoxemia (SpO2 < 85% for at least 1 minute) occurs during the recruitment maneuver maneuver, the procedure is terminated, and ventilator settings are returned to the parameters used prior to the recruitment maneuver.
Low FiO2 - PEEP table In the control group, patients set PEEP by low FiO2-PEEP table based on ARDSnet protocol.
- Conditions
- Acute Respiratory Syndrome Distress, Positive End-Expiratory Pressure, Mechanical Ventilation, Electrical Impedance Tomography (EIT)
- Being tested
- electrical impedance tomography, Non-EIT
- Keywords
- Acute respiratory syndrome distress, Mechanical Ventilation, Positive End-Expiratory Pressure, electrical impedance tomography, blood oxygenation, pulmonary mechanics
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical impedance tomographyDevice
Before initiating recruitment maneuver, all patients were placed on mechanical ventilation set according to the ARDSnetwork strategy for 10 minutes, ensuring SpO2 of 88-95%, PaO2 of 55-80 mmHg, and a mean arterial pressure (MAP) ≥ 65 mmHg.
- PEEP was incrementally increased by 5 cmH2O every minute: from 10 to 15, to 20, and finally to 25 cmH2O, with a maximum pressure limit of 40 cmH2O.
- Following recruitment maneuver at the final PEEP level, the process of identifying the optimal PEEP was initiated.
- Then, PEEP will be set to 20 cmH2O and was gradually decreased by 2 cmH2O every 30 seconds until it reached 6 cmH2O or SpO2 dropped to ≤ 80%.
- Selection of optimal PEEP: The optimal PEEP was defined as the intersection point between the alveolar overdistension and collapse curves as measured by the EIT system.
Non-EITOther
Patients will have PEEP set using the low FiO2-PEEP table, based on the ARDSnet protocol
| Study group | Role | What they receive |
|---|---|---|
| EIT-PEEP setting | Active comparator | Patients will have PEEP settings determined by EIT guidance following a stepwise decremental PEEP trial Receives: Device: electrical impedance tomography |
| ARDSNet-PEEP setting | Placebo comparator | PEEP will be adjusted using the low FiO2-PEEP table to achieve oxygenation targets: SpO2 between 88% and 95% and PaO2 between 55 mmHg and 80 mmHg Receives: Other: Non-EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
PaO2/FiO2 will be evaluated via arterial blood gas analysis every day during the first week treatment.
Measured: at day 1, 2, 3, 4, 5, 6, 7
Pulmonary Mechanic
Static Compliance
Measured: at day 1, 2, 3, 4, 5, 6, 7
Secondary outcomes (7)
Ventilator free days
Ventilator free days
Measured: up to 28 days
Length of ICU stay
Days of ICU stay
Measured: up to 28 days
Length of mechanical ventilated days
Days of received mechanical ventilation
Measured: up to 28 days
Pneumothorax or barotrauma
new-onset of pneumothorax and barotrauma
Measured: up to 28 days
Rescue therapies
Neuromuscular blocker, prone postition, ECMO
Measured: up to 7 days
SOFA
Sequential Organ Failure Assessment
Measured: at day 1, 3, 7
Mortality
the survival rate(survival/total) during hospital stay
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 Aug 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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 Acute Respiratory Syndrome DistressStudies 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
- Prospective, single center, ramdomized controlled trial
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietnam Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University, Bach Mai Hospital
- Responsible party
- Principal investigator, Nguyen Dang Thu, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733168
- Sponsor's protocol ID
- TrungHSTC 5532/BM-HDDD
- Acronym
- PEEP
- Status last verified
- Aug 2024
- First submitted
- 9 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
PubMed 19255741Jimenez JV, Weirauch AJ, Culter CA, Choi PJ, Hyzy RC. Electrical Impedance Tomography in Acute Respiratory Distress Syndrome Management. Crit Care Med. 2022 Aug 1;50(8):1210-1223. doi: 10.1097/CCM.0000000000005582. Epub 2022 May 23.
PubMed 35607967Matthay 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 37487152Trung DV, Giang BTH, Tuan DQ, Tan NC, Thach PT, Cuong BV, Cuong NB, Anh TT, Thu ND, Son DN. Respiratory effects of recruitment maneuvers according to lung recruitability assessed by electrical impedance tomography in patients with acute respiratory distress syndrome. J Clin Monit Comput. 2026 Jul 24. doi: 10.1007/s10877-026-01473-5. Online ahead of print.
PubMed 42496809Van Trung D, Giang BTH, Tuan DQ, Tan NC, Thach PT, Van Cuong B, Cuong NB, Anh TT, Anh NT, Van Huy N, Trieu HD, Van Trong N, Trang TT, Toan VX, Nam NH, Sam NT, Thanh TM, Dat NT, Hong NTP, Phuong PTH, Hien DD, Van Hoi D, Phong HT, Thu ND, Trang NT, Hieu NX, Dat HT, Phuong DX, Son DN. The impact of PEEP-guided electrical impedance tomography on oxygenation and respiratory mechanics in moderate-to-severe ARDS: a randomized controlled trial. Sci Rep. 2025 Nov 29;16(1):391. doi: 10.1038/s41598-025-29787-5.
PubMed 41318662
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe ARDS
- ClinicalTrials.gov ID
- NCT06733168
- Acronym / sponsor ID
- PEEP / TrungHSTC 5532/BM-HDDD
- Conditions
- Acute Respiratory Syndrome Distress, Positive End-Expiratory Pressure, Mechanical Ventilation, Electrical Impedance Tomography (EIT)
- Keywords
- Acute respiratory syndrome distress, Mechanical Ventilation, Positive End-Expiratory Pressure, electrical impedance tomography, blood oxygenation, pulmonary mechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Vietnam Military Medical UniversityUniversity, hospital or other
- Collaborators
- Hanoi Medical University, Bach Mai Hospital
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Dec 2024 (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.
Acute respiratory distress syndrome (ARDS) in its moderate to severe forms is associated with high mortality. Mechanical ventilation (MV) remains the cornerstone of ARDS management but carries a significant risk of ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP), a fundamental component of MV, is widely utilized in clinical practice; however, optimal PEEP selection for patients with moderate to severe ARDS remains a complex and unresolved challenge. Electrical impedance tomography (EIT), a bedside imaging modality that evaluates regional ventilation distribution, offers a means of individualizing PEEP settings in mechanically ventilated patients. By balancing the competing risks of alveolar overdistension and collapse, EIT facilitates precision in PEEP titration. This study compares the impact of EIT-guided PEEP selection versus the conventional low FiO2-PEEP table on blood oxygenation and pulmonary mechanics.
Detailed description
This is a prospective, single-center, randomized controlled trial designed to evaluate the effects of PEEP settings guided by electrical impedance tomography (EIT) on clinical outcomes in patients with moderate to severe ARDS undergoing lung-protective ventilation. Adult intubated patients with moderate to severe ARDS will be enrolled in the study.
Patients in the intervention group will receive PEEP titrated using EIT with a stepwise decremental PEEP trial, while those in the control group will have PEEP set based on the FiO2-PEEP table. Other ventilator parameters will be managed according to the ARDSnet protocol.
The primary outcomes are blood oxygenation and pulmonary mechanics. Secondary outcomes include 28-day mortality, ventilator-free and shock-free days at 28 days, length of ICU and hospital stay, rate of successful weaning, the proportion requiring rescue therapies, complications, respiratory variables, and the Sequential Organ Failure Assessment (SOFA) score.
Before initiating recruitment maneuver, all patients were placed on mechanical ventilation set according to the ARDS network strategy for 10 minutes, ensuring SpO2 of 88-95%, PaO2 of 55-80 mmHg, and a mean arterial pressure (MAP) ≥ 65 mmHg.
- Patients received sedation and neuromuscular blockade to achieve full synchronization with the ventilator (RASS ≤ -3).
- The mode was set to Pressure-Controlled Ventilation (PCV): ΔP = 15 cmH2O, which was maintained constant during the recruitment maneuver, while FiO2, PEEP, and respiratory rate were kept as previously set.
- PEEP was incrementally increased by 5 cmH2O every minute: from 10 to 15, to 20, and finally to 25 cmH2O, with a maximum pressure limit of 40 cmH2O.
- Following the recruitment maneuver at the final PEEP level, the process of identifying the optimal PEEP was initiated.
- Then, PEEP will be set to 20 cmH2O and gradually decreased by 2 cmH2O every 30 seconds until it reached 6 cmH2O or SpO2 dropped to ≤ 80%.
- Selection of optimal PEEP: The optimal PEEP was defined as the intersection point between the alveolar overdistension and collapse curves as measured by the EIT system.
- Termination Criteria: If persistent hypotension (mean arterial pressure decrease > 15 mmHg) or sustained hypoxemia (SpO2 < 85% for at least 1 minute) occurs during the recruitment maneuver maneuver, the procedure is terminated, and ventilator settings are returned to the parameters used prior to the recruitment maneuver.
Low FiO2 - PEEP table In the control group, patients set PEEP by low FiO2-PEEP table based on ARDSnet protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single center, ramdomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EIT-PEEP setting | Active comparator | Device: electrical impedance tomographyPatients will have PEEP settings determined by EIT guidance following a stepwise decremental PEEP trial |
| ARDSNet-PEEP setting | Placebo comparator | Other: Non-EITPEEP will be adjusted using the low FiO2-PEEP table to achieve oxygenation targets: SpO2 between 88% and 95% and PaO2 between 55 mmHg and 80 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Intubated moderate and severe ARDS according to the New Global Definition (PaO2/FiO2 ≤200 mmHg).
- Used continuous sedation with or without paralysis.
Key exclusion criteria (5 listed)
- Presence of pneumothorax that is either undrained or newly occurred.
- Unstable hemodynamics with a mean arterial pressure < 60 mmHg and unresponsive to resuscitation measures, and/or heart rate < 60 bpm.
- Contraindications for EIT (pacemakers, automatic external defibrillators, cases of chest trauma or recent chest surgery limiting EIT belt application).
- Pregnancy.
- Severe neuromuscular disease.
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 |
|---|---|---|
| electrical impedance tomographyBefore initiating recruitment maneuver, all patients were placed on mechanical ventilation set according to the ARDSnetwork strategy for 10 minutes, ensuring SpO2 of 88-95%, PaO2 of 55-80 mmHg, and a mean arterial pressure (MAP) ≥ 65 mmHg. * PEEP was incrementally increased by 5 cmH2O every minute: from 10 to 15, to 20, and finally to 25 cmH2O, with a maximum pressure limit of 40 cmH2O. * Following recruitment maneuver at the final PEEP level, the process of identifying the optimal PEEP was initiated. * Then, PEEP will be set to 20 cmH2O and was gradually decreased by 2 cmH2O every 30 seconds until it reached 6 cmH2O or SpO2 dropped to ≤ 80%. * Selection of optimal PEEP: The optimal PEEP was defined as the intersection point between the alveolar overdistension and collapse curves as measured by the EIT system. | Device | EIT-PEEP setting |
| Non-EITPatients will have PEEP set using the low FiO2-PEEP table, based on the ARDSnet protocol | Other | ARDSNet-PEEP setting |
Primary outcome
Oxygenation
Time frame: at day 1, 2, 3, 4, 5, 6, 7
PaO2/FiO2 will be evaluated via arterial blood gas analysis every day during the first week treatment.
Pulmonary Mechanic
Time frame: at day 1, 2, 3, 4, 5, 6, 7
Static Compliance
7 secondary outcomes
Ventilator free days
Time frame: up to 28 days
Length of ICU stay
Time frame: up to 28 days
Length of mechanical ventilated days
Time frame: up to 28 days
Pneumothorax or barotrauma
Time frame: up to 28 days
Rescue therapies
Time frame: up to 7 days
SOFA
Time frame: at day 1, 3, 7
Mortality
Time frame: up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Results publication: PubMed 19255741Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
- Results publication: PubMed 35607967Jimenez JV, Weirauch AJ, Culter CA, Choi PJ, Hyzy RC. Electrical Impedance Tomography in Acute Respiratory Distress Syndrome Management. Crit Care Med. 2022 Aug 1;50(8):1210-1223. doi: 10.1097/CCM.0000000000005582. Epub 2022 May 23.
- 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.
- Derived from this study: PubMed 42496809Trung DV, Giang BTH, Tuan DQ, Tan NC, Thach PT, Cuong BV, Cuong NB, Anh TT, Thu ND, Son DN. Respiratory effects of recruitment maneuvers according to lung recruitability assessed by electrical impedance tomography in patients with acute respiratory distress syndrome. J Clin Monit Comput. 2026 Jul 24. doi: 10.1007/s10877-026-01473-5. Online ahead of print.
- Derived from this study: PubMed 41318662Van Trung D, Giang BTH, Tuan DQ, Tan NC, Thach PT, Van Cuong B, Cuong NB, Anh TT, Anh NT, Van Huy N, Trieu HD, Van Trong N, Trang TT, Toan VX, Nam NH, Sam NT, Thanh TM, Dat NT, Hong NTP, Phuong PTH, Hien DD, Van Hoi D, Phong HT, Thu ND, Trang NT, Hieu NX, Dat HT, Phuong DX, Son DN. The impact of PEEP-guided electrical impedance tomography on oxygenation and respiratory mechanics in moderate-to-severe ARDS: a randomized controlled trial. Sci Rep. 2025 Nov 29;16(1):391. doi: 10.1038/s41598-025-29787-5.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical impedance tomography and Non-EIT in people with Acute Respiratory Syndrome Distress and Positive End-Expiratory Pressure, run by Vietnam Military Medical University at 1 site in Vietnam.
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 3 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 Vietnam. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trung Van Dinh, MD ((+84) 988519190, dinhvantrung.ptgh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation (time frame: at day 1, 2, 3, 4, 5, 6, 7). 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 NCT06733168, 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 13 Dec 2024.