Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06733168

The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe ARDS

Led by Vietnam Military Medical University · Updated on 2024-12-13

76

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

Sponsors

V

Vietnam Military Medical University

Lead Sponsor

H

Hanoi Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare two methods of setting positive end-expiratory pressure (PEEP) in adults with moderate to severe acute respiratory distress syndrome (ARDS) who require mechanical ventilation. ARDS is linked to high mortality, and while mechanical ventilation is essential, it can cause lung injury. The study focuses on whether using electrical impedance tomography (EIT) to guide PEEP settings improves blood oxygenation and lung function compared to the traditional low FiO2-PEEP table approach. Participants will be randomly assigned to one of two groups. The intervention group will have PEEP adjusted using EIT guidance with a stepwise decremental PEEP trial, which involves increasing and then gradually decreasing PEEP while monitoring lung overdistension and collapse. The control group will have PEEP set according to the low FiO2-PEEP table based on standard ARDSnet protocol. Both groups will receive lung-protective ventilation with sedation and neuromuscular blockade to synchronize with the ventilator. Throughout the study, researchers will monitor blood oxygen levels and lung mechanics daily for seven days. Additional assessments include ventilator-free days, length of intensive care unit stay, mechanical ventilation duration, complications such as pneumothorax, rescue therapy use, organ failure scores, and mortality up to two months. Patient safety is closely observed during PEEP adjustments, with criteria to stop procedures if significant blood pressure or oxygen drops occur. The study duration for each participant includes these daily assessments over a week and follow-up for two months.

CONDITIONS

Brief Title

The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe ARDS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Intubated patients with moderate to severe ARDS defined by PaO2/FiO2 ratio of 200 mmHg or less
  • Patients receiving continuous sedation with or without paralysis
Not Eligible

You will not qualify if you...

  • Presence of undrained or newly developed pneumothorax
  • Unstable hemodynamics with mean arterial pressure below 60 mmHg unresponsive to treatment and/or heart rate below 60 bpm
  • Contraindications to EIT including pacemakers, automatic external defibrillators, recent chest trauma, or chest surgery preventing EIT belt use
  • Pregnancy
  • Severe neuromuscular disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 lung-protective ventilation with PEEP settings determined either by electrical impedance tomography guidance or by the low FiO2-PEEP table based on the ARDSnet protocol. Ventilator parameters are managed according to the ARDSnet strategy, with active adjustment of PEEP to optimize oxygenation and pulmonary mechanics.

Daily assessments for up to 7 days with ongoing monitoring up to 28 days

Follow-up

Duration - Up to 2 months

Participants are monitored for clinical outcomes including ventilator-free days, length of ICU stay, complications, and mortality up to 2 months after treatment.

Periodic assessments including mortality and clinical status

Trial Site Locations

Total: 1 location

1

Intensive Care Center, Bach Mai Hospital

Hanoi, Vietnam

Actively Recruiting

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Research Team

T

Trung Van Dinh, MD

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

The impact of PEEP-guided electrical impedance tomography on oxygenation and respiratory mechanics in moderate-to-severe ARDS: a randomized controlled trial.

Dinh Van Trung, Bui Thi Huong Giang, Dang Quoc Tuan...

https://pubmed.ncbi.nlm.nih.gov/41318662