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Acute Respiratory Syndrome DistressEIT-PEEP-SURGNCT07313644

EIT-Guided PEEP Optimization in Trauma and Postoperative ARDS

A study testing EIT-giuded PEEP in people with Acute Respiratory Syndrome Distress and Positive End-Expiratory Pressure, run by Nguyen Dang Thu 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) remains a serious and often fatal complication in patients following severe trauma or major surgery. Mechanical ventilation is essential for supportive care in this population, but may aggravate lung injury when suboptimal ventilatory settings are applied. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
EIT-giuded PEEP
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteVietnam
Study dates
15 Mar 2025to 15 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mechanically ventilated surgical intensive care patients with trauma- or postoperative-associated moderate to severe ARDS, as defined by the 2023 Global Definition of ARDS.

Who cannot join

  • Age <18 or >90 years.
  • Severe acute brain injury or acute stroke with Glasgow Coma Scale <8.
  • Thoracic trauma with pneumothorax or pneumomediastinum.
  • End-stage diseases under palliative care (e.g., metastatic cancer, cirrhosis, end-stage renal disease).
  • Severe multiorgan failure with expected survival <7 days.
  • Conditions requiring prolonged mechanical ventilation (e.g., Guillain-Barré syndrome, cervical spinal cord injury).
Show all 12Show fewer
  • Contraindications to hypercapnia (e.g., elevated intracranial pressure, acute coronary syndrome).
  • Prior use of advanced respiratory therapies (e.g., ECMO, inhaled nitric oxide, prone positioning, high-frequency ventilation).
  • Pregnancy, breastfeeding, or skin lesions at electrode placement sites.
  • Implanted electrical devices interfering with EIT (e.g., pacemaker, ICD).
  • Known allergy to electrode materials.
  • Refusal to participate or concurrent enrollment in another study

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
  • Center for Anesthesia and Surgical Intensive Care, Viet Duc University Hospital

    Hanoi, 10000

    Luu Quang Thuy, Ass.Prof; Ph.D; M.D, (+84) 93608899

    Nguyen Viet Minh, M.D

    Recruiting

Other trials in Vietnam

About this study

Official title: Electrical Impedance Tomography-Guided Positive End-Expiratory Pressure Optimization in Patients With Trauma-Related and Postoperative Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) remains a serious and often fatal complication in patients following severe trauma or major surgery. Mechanical ventilation is essential for supportive care in this population, but may aggravate lung injury when suboptimal ventilatory settings are applied. Positive end-expiratory pressure (PEEP) is crucial for maintaining alveolar recruitment; however, optimal PEEP selection in trauma- or postoperative-associated ARDS remains uncertain. Electrical impedance tomography (EIT) enables bedside, real-time assessment of regional ventilation and may support optimal PEEP titration by balancing alveolar overdistension and collapse. This study compares EIT-guided PEEP optimization with the conventional low FiO₂-PEEP strategy in terms of oxygenation and respiratory mechanics in patients with moderate to severe ARDS following trauma or surgery.

Read the detailed description

This single-center, prospective, randomized controlled trial was designed to evaluate whether EIT-guided PEEP titration improves clinical outcomes in patients with trauma- or postoperative-associated ARDS. Adult intubated patients with moderate to severe ARDS were enrolled.

Patients in the intervention group received PEEP settings guided by electrical impedance tomography, whereas those in the control group were managed according to the lower PEEP/FiO₂ table of the ARDS Network. Other ventilatory parameters and oxygenation targets were set in accordance with ARDS Network recommendations. Supportive care and post-trial PEEP management followed standard ARDS treatment protocols.

The primary outcomes included oxygenation and respiratory mechanics. The secondary outcomes comprised 28-day survival, ventilator-free days at day 28, length of ICU and length of hospital stay, rate of successful ventilator weaning, use of adjunctive therapies (prone positioning, neuromuscular blockade, ECMO), newly developed barotrauma (pneumothorax, pneumomediastinum, and subcutaneous emphysema) excluding cases attributable to invasive procedures) and changes in the SOFA score.

In the intervention group, PEEP was titrated under the guidance of electrical impedance tomography (EIT) according to a protocol:

  • Preparation: patients underwent airway suctioning and were deeply sedated (RASS ≤ -3) to abolish spontaneous breathing. PEEP titration was performed using an EIT system (Enlight 2100, Timpel SA, Brazil), with a silicone belt containing 32 surface electrodes positioned at the fourth to fifth intercostal space in accordance with the manufacturer's instructions.
  • Pressure-controlled ventilation was applied with an inspiration pressure set at 15 cmH₂O and a set PEEP of 24 cmH₂O, with a maximum airway pressure limit of 40 cmH₂O. Ventilator settings were maintained for 30 seconds with an FiO₂ of 1.0. A decremental PEEP trial was then performed by reducing PEEP in 2 cmH₂O every 30 seconds until a PEEP of 6 cmH₂O was reached or the SpO₂ decreased to ≤ 80%.
  • The EIT-guided optimal PEEP was defined as the PEEP level corresponding to the intersection point of the collapse and overdistension curves.

Criteria for discontinuing: PEEP titration was terminated if any of the following occurred: a sustained decrease in mean arterial pressure of > 20 mmHg from baseline, SpO₂ < 88%, or the onset of new cardiac arrhythmias. If the event of discontinuation of the procedure, all ventilator settings were reverted to those applied prior to initiation of the PEEP titration.

In the control group, PEEP was set directly and adjusted according to the lower PEEP/FiO₂ table of the ARDS Network.

Being tested
EIT-giuded PEEP, Control
Keywords
Acute respiratory syndrome distress, Positive End-Expiratory Pressure, electrical impedance tomography, Trauma and Postoperative, blood oxygenation, pulmonary mechanics
Medical subject headings
Respiratory Distress Syndrome, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EIT-giuded PEEPDevice

    Device: electrical impedance tomography system (Enlight 2100, Timpel SA, Brazil).

    • Patients underwent airway suctioning and were deeply sedated (RASS ≤ -3) to abolish spontaneous breathing. PEEP titration was performed using an EIT system (Enlight 2100, Timpel SA, Brazil), with a silicone belt containing 32 surface electrodes positioned at the fourth to fifth intercostal space in accordance with the manufacturer's instructions.

    Pressure-controlled ventilation was applied with an inspiration pressure set at 15 cmH₂O and a set PEEP of 24 cmH₂O, with a maximum airway pressure limit of 40 cmH₂O. Ventilator settings were maintained for 30 seconds with an FiO₂ of 1.0. A decremental PEEP trial was then performed by reducing PEEP in 2 cmH₂O every 30 seconds until a PEEP of 6 cmH₂O was reached or the SpO₂ decreased to ≤ 80%.

    The EIT-guided optimal PEEP was defined as the PEEP level corresponding to the intersection point of the collapse and overdistension curves.

  • ControlDevice

    PEEP was set and adjusted according to the lower PEEP/FiO₂ table of the ARDS Network

Study groups in NCT07313644
Study groupRoleWhat they receive
Intervention GroupActive comparatorDevice: electrical impedance tomography system (Enlight 2100, Timpel SA, Brazil). - Patients underwent airway suctioning and were deeply sedated (RASS ≤ -3) to abolish spontaneous breathing. PEEP titration was performed using an EIT system (Enlight 2100, Timpel SA, Brazil), with a silicone belt containing 32 surface electrodes positioned at the fourth to fifth intercostal space in accordance with the manufacturer's instructions. Pressure-controlled ventilation was applied with an inspiration pressure set at 15 cmH₂O and a set PEEP of 24 cmH₂O, with a maximum airway pressure limit of 40 cmH₂O. Ventilator settings were maintained for 30 seconds with an FiO₂ of 1.0. A decremental PEEP trial was then performed by reducing PEEP in 2 cmH₂O every 30 seconds until a PEEP of 6 cmH₂O was reached or the SpO₂ decreased to ≤ 80%. The EIT-guided optimal PEEP was defined as the PEEP level corresponding to the intersection point of the collapse and overdistension curves.
Receives: Device: EIT-giuded PEEP
Control GroupPlacebo comparatorPEEP was set and adjusted according to the lower PEEP/FiO₂ table of the ARDS Network
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygenation

    PaO₂/FiO₂ ratio

    Measured: at day 0, 1, 2, 3

  2. Pulmonary Mechanics

    Static Compliance

    Measured: at day 0, 1, 2, 3

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. Barotrauma

    pneumothorax, pneumomediastinum, and subcutaneous emphysema

    Measured: up to 28 days

  5. Rescue therapies

    Neuromuscular blocker using, prone postition, ECMO

    Measured: up to 7 days

  6. SOFA

    Sequential Organ Failure Assessment

    Measured: at day 0, 1, 2, 3

  7. Mortality

    In-hospital mortality rate

    Measured: up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start15 Mar 2025
  3. Primary completion15 Aug 2026 (estimated)
  4. Study completion15 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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07313644
Sponsor's protocol ID
MinhGMHS 1879/GCN-HMUIRB
Acronym
EIT-PEEP-SURG
Status last verified
Dec 2025
First submitted
17 Dec 2025
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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
  • Gao Y, He H, Chi Y, Frerichs I, Long Y, Zhao Z. Electrical impedance tomography guided positive end-expiratory pressure titration in critically ill and surgical adult patients: a systematic review and meta-analysis. BMC Pulm Med. 2024 Nov 23;24(1):582. doi: 10.1186/s12890-024-03394-y.

    PubMed 39580405

Questions about this trial

What is this clinical trial studying?

A study testing EIT-giuded PEEP in people with Acute Respiratory Syndrome Distress and Positive End-Expiratory Pressure, run by Nguyen Dang Thu 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 1 inclusion and 12 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 2 Jan 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 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 Nguyen Viet Minh ((+84) 918292528, vietminh1510@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 0, 1, 2, 3). 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 NCT07313644, which also lists 3 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 2 Jan 2026.

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