Study of PEEP Settings Guided by Electrical Impedance Tomography Versus Standard FiO2-PEEP Table in Adults with Moderate to Severe ARDS on Mechanical Ventilation
Led by Vietnam Military Medical University · Updated on 2024-12-13
76
Participants Needed
1
Research Sites
2 weeks
Total Duration
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
Research Team
T
Trung Van Dinh, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
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
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
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
The PEARL Trial Testing Warm Amnioinfusion to Reduce Newborn Breathing Problems and Support Long-Term Child Development After Thick Meconium Exposure in Late Pregnancy
Study Comparing Pain-First Sedation vs. Standard Sedation for Trauma Patients on Mechanical Ventilation
Observing Breathing Effort at Different Pressure Support Levels in Adults After Major Abdominal Surgery in the ICU
Study of Amino Acid Infusion to Prevent Acute Kidney Injury
and Reduce Ventilator Use in Children After Heart Surgery
Brain Function and Blood Flow Monitoring During PEEP Respiratory Therapy in Critically Ill Patients with Acute Brain Injury
Trial to Improve Extubation Timing in Brain-Injured Patients
Using a Clinical Score to Reduce Extubation Failure
in Adults Aged 18 to 75 on Mechanical Ventilation
Study on Calibrating Esophageal Balloon Catheter During Spontaneous and Mandatory Mechanical Ventilation for Better Patient Care
Developing a Machine Learning Model Using Chest X-Ray and Blood Gas Tests to Predict Mechanical Ventilation Need in Critically Ill Adults
COMPARE-VENT Pilot Study Evaluating Pressure-Controlled Versus Volume-Controlled Ventilation in Critically Ill Cardiac Patients on Mechanical Breathing Support
Study Comparing Standard and Modified High-Flow Tracheal Oxygen to T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Adults
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
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...
Respiratory effects of recruitment maneuvers according to lung recruitability assessed by electrical impedance tomography in patients with acute respiratory distress syndrome.
Dinh Van Trung, Bui Thi Huong Giang, Dang Quoc Tuan...