EIT-Guided PEEP Optimization in Trauma and Postoperative ARDS

NCT07313644 | Recruiting

• 1 other identifier: MinhGMHS 1879/GCN-HMUIRB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Respiratory Syndrome Distress; Positive End-Expiratory Pressure; Electrical Impedance Tomography; Trauma and Postoperative Pulmonary Insufficiency

Keywords

Acute respiratory syndrome distress; Positive End-Expiratory Pressure; electrical impedance tomography; Trauma and Postoperative; blood oxygenation; pulmonary mechanics

Outcome Measures

Primary Outcomes (2)

• Oxygenation

  PaO₂/FiO₂ ratio

  at day 0, 1, 2, 3

• Pulmonary Mechanics

  Static Compliance

  at day 0, 1, 2, 3

Secondary Outcomes (7)

• Ventilator free days

  up to 28 days

• Length of ICU stay

  up to 28 days

• Length of mechanical ventilated days

  up to 28 days

• Barotrauma

  up to 28 days

• Rescue therapies

  up to 7 days

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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.

Device: EIT-giuded PEEP

Control Group

PLACEBO COMPARATOR

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

Device: Control

Interventions

EIT-giuded PEEP DEVICE

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.

Intervention Group

Control DEVICE

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

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Hanoi Medical University: collaborator
• Viet Duc University Hospital: collaborator
• Nguyen Dang Thu: lead

Study Sites (1)

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

Hanoi, 10000, Vietnam

RECRUITING

Related Publications (3)

• 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.

  PMID: 19255741 BACKGROUND

• 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.

  PMID: 35607967 BACKGROUND

• 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.

  PMID: 39580405 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Wounds and Injuries

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Nguyen Viet Minh

CONTACT

(+84) 918292528; vietminh1510@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D; M.D.

Model Details: Prospective, single center, ramdomized controlled trial

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: March 15, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

VN (1)