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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • Intensive Care Center, Bach Mai Hospital

    Hanoi

    Son Ngoc Do, Prof. PhD. MD, (+84) 914669880, sonngocdo@gmail.com

    Recruiting

Other trials in Vietnam

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.

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 groups in NCT06733168
Study groupRoleWhat they receive
EIT-PEEP settingActive comparatorPatients will have PEEP settings determined by EIT guidance following a stepwise decremental PEEP trial
Receives: Device: electrical impedance tomography
ARDSNet-PEEP settingPlacebo comparatorPEEP 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.

  1. 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

  2. Pulmonary Mechanic

    Static Compliance

    Measured: at day 1, 2, 3, 4, 5, 6, 7

Secondary outcomes (7)
  1. Ventilator free days

    Ventilator free days

    Measured: up to 28 days

  2. Length of ICU stay

    Days of ICU stay

    Measured: up to 28 days

  3. Length of mechanical ventilated days

    Days of received mechanical ventilation

    Measured: up to 28 days

  4. Pneumothorax or barotrauma

    new-onset of pneumothorax and barotrauma

    Measured: up to 28 days

  5. Rescue therapies

    Neuromuscular blocker, prone postition, ECMO

    Measured: up to 7 days

  6. SOFA

    Sequential Organ Failure Assessment

    Measured: at day 1, 3, 7

  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.

  1. First posted13 Dec 2024
  2. Study start15 Aug 2024
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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)
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 19255741
  • Jimenez 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 35607967
  • Matthay 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 37487152
  • Trung 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 42496809
  • Van 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

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.

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