Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID07313644

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

Led by Nguyen Dang Thu · Updated on 2026-01-02

80

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

N

Nguyen Dang Thu

Lead Sponsor

H

Hanoi Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of electrical impedance tomography (EIT) to guide positive end-expiratory pressure (PEEP) settings in patients with moderate to severe acute respiratory distress syndrome (ARDS) following trauma or major surgery. ARDS can be a serious complication requiring mechanical ventilation, but improper ventilator settings may worsen lung injury. This study aims to compare EIT-guided PEEP optimization with the conventional low oxygen and PEEP strategy to improve oxygen levels and respiratory function. The study randomly assigns adult patients to two groups. One group receives PEEP adjustments based on EIT, a bedside imaging device that monitors lung ventilation in real time. This involves sedation, airway suctioning, and a stepwise reduction of PEEP while monitoring lung collapse and overdistension to find the optimal PEEP level. The control group receives PEEP settings according to standard ARDS Network guidelines using a low oxygen and PEEP table. Both groups follow recommended ventilation and oxygenation protocols. Participants will be monitored for oxygenation and lung mechanics at baseline and daily for four days. Secondary measures include survival at 28 days, ventilator-free days, ICU and hospital stay lengths, barotrauma occurrence, use of rescue therapies, and organ function scores. Safety assessments include monitoring for blood pressure drops, oxygen saturation, and arrhythmias during PEEP titration. The trial will continue until December 2026, with comprehensive evaluations to assess the effects of EIT-guided PEEP on clinical outcomes in ARDS patients after trauma or surgery.

CONDITIONS

Brief Title

EIT-Guided PEEP Optimization in Trauma and Postoperative ARDS

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mechanically ventilated surgical intensive care patients with trauma- or postoperative-associated moderate to severe ARDS, as defined by the 2023 Global Definition of ARDS.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 28 days

Participants receive PEEP optimization using either electrical impedance tomography-guided titration or standard lower PEEP/FiO₂ table management while mechanically ventilated in the ICU.

Daily assessments for up to 4 days; ongoing ventilator management up to 28 days

Follow-up

Duration - Up to 28 days

Participants are monitored for clinical outcomes such as ventilator-free days, length of ICU stay, barotrauma, rescue therapies, organ function scores, and survival up to 28 days after treatment initiation.

Regular assessments during ICU stay up to day 28

Trial Site Locations

Total: 1 location

1

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

Hanoi, Vietnam, 10000

Actively Recruiting

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Research Team

N

Nguyen Viet Minh

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography.

Eduardo L V Costa, João Batista Borges, Alexandre Melo...

https://pubmed.ncbi.nlm.nih.gov/19255741

Electrical impedance tomography guided positive end-expiratory pressure titration in critically ill and surgical adult patients: a systematic review and meta-analysis.

Yelin Gao, Huaiwu He, Yi Chi...

https://pubmed.ncbi.nlm.nih.gov/39580405