EIT-Guided Ventilator Settings in AHRF

NCT06936618 | Recruiting

• 1 other identifier: SI 962/2024
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study aims to investigate the effect of Electrical Impedance Tomography (EIT)-guided ventilator settings on mechanical power in patients with acute hypoxemic respiratory failure (AHRF), including both ARDS and non-ARDS conditions. Mechanical power, a key factor associated with ventilator-induced lung injury (VILI), will be measured before and after EIT-guided PEEP titration. The study will evaluate feasibility and changes in lung mechanics, gas exchange, and EIT parameters. A total of 17 patients requiring invasive mechanical ventilation will be enrolled at Siriraj Hospital, Mahidol University.

Conditions

Acute Hypoxemic Respiratory Failure; Acute Respiratory Distress Syndrome (ARDS); Mechanical Power; Ventilator Induced Lung Injury; Electrical Impedance Tomography (EIT)

Keywords

Acute Hypoxemic Respiratory Failure; Electrical Impedance Tomography; Mechanical Power, Ventilator-induced lung injury

Outcome Measures

Primary Outcomes (1)

• Change in Mechanical Power

  Mechanical power (MP) will be calculated using Gattinoni's simplified formula. Simplified Gattinoni's formula: MP = 0.098 × respiratory rate × tidal volume × \[peak inspiratory pressure - (plateau pressure - PEEP)/2\] calculated mechanical power (measured in J/min) before and after using EIT-guided PEEP titration in patients with acute hypoxemic respiratory failure. Unit of Measure: Joules per minute (J/min)

  ฺBaseline and 2 hours after EIT-guided ventilator adjustment and follow-up over 24 hours (baseline, 2 hours, 12 hours, and 24 hours after EIT-guided ventilator adjustment)

Secondary Outcomes (14)

• Change in PEEP level

  At baseline and then 2 hours, 12 hours, 24 hours after EIT-guided PEEP titration

• Change in Respiratory Static Compliance

  Baseline, 2 hours, 12 hours, and 24 hours after intervention

• Change in Driving Pressure

  Baseline, 2 hours, 12 hours, and 24 hours after intervention

• Change in Plateau Pressure

  Baseline, 2 hours, 12 hours, and 24 hours after intervention

• Change in 4∆P + RR Index

  Baseline, 2 hours, 12 hours, and 24 hours after intervention

Study Arms (1)

EIT-guided PEEP titration

EXPERIMENTAL

Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics.

Device: Electrical Impedance Tomography (EIT), Enlight 2100

Interventions

Electrical Impedance Tomography (EIT), Enlight 2100 DEVICE

Patients will undergo ventilator adjustments using EIT-guided PEEP titration to optimize mechanical power and lung mechanics.

EIT-guided PEEP titration

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Diagnosed with acute hypoxemic respiratory failure within 48 hours
• Expected to require invasive mechanical ventilation ≥ 48 hours
• On mechanical ventilation within 24 hours
• Deep sedation and neuromuscular blockade

You may not qualify if:

• Pregnancy
• Body mass index (BMI) \> 40 kg/m2
• Contraindications to using electrical impedance tomography, including
• Presence of a pacemaker or automatic implantable cardioverter-defibrillator (AICD)
• Inability to place the belt due to presence of surgical wounds dressing, thoracic or spinal cord trauma, recent thoracic surgery, etc.
• High risk for PEEP titration
• Hemodynamic instability defined as mean arterial pressure \< 65 mmHg despite optimization of fluid status and/or use of vasopressors
• Unstable cardiac arrhythmias
• Presence of lung bullae greater than 2 cm in diameter, identified on chest X-ray
• Presence of pneumothorax or pneumomediastinum
• Right-sided heart failure or severe pulmonary hypertension
• Neurologic conditions associated with a risk of intracranial hypertension
• Use of extracorporeal membrane oxygenation (ECMO)
• Severe chronic respiratory disease, defined as follows: requiring home oxygen therapy, or previous lung function showing (FEV1 less than 20 ml/kg PBW, or FEV1/FVC less than 50% predicted value), or chronic hypercapnia (PaCO2 greater than 45 mmHg) and/or chronic hypoxemia (PaO2 less than 55 mmHg) on FIO2 = 0.21, or radiographic x-ray evidence of any chronic over-inflation or chronic interstitial infiltration, or chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (unable to climb stairs or perform household duties, secondary polycythemia, severe pulmonary hypertension with mean pulmonary arterial pressure greater than 40 mmHg)
• Decision to withhold life-sustaining treatment or palliative care.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Lung Injury

Study Officials

• Ranistha Ratanarat, Associated Professor, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jitanong Sootlek, MD, PCCM

CONTACT

+66954164563; jitanong9651@gmail.com

Ranistha Ratanarat, MD, Nephrology, Critical care

CONTACT

+66896685287; ranittha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled patients will receive the intervention using EIT-guided PEEP titration. Outcomes such as mechanical power, lung mechanics, and gas exchange will be measured before and after the intervention in a single-arm, pre-post study design.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 20, 2025
• Study Start: December 17, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)