Effect of Electric Impedance Tomography-Guided PEEP Titration

Effect of Electric Impedance Tomography-Guided PEEP Titration on the Ventilation-perfusion Mismatch in Moderate or Severe ARDS

Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, how to best set PEEP is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the ventilation-perfusion mismatch.

Study Overview

• Status: Completed
• Conditions: ARDS, Human
• Intervention / Treatment: Device: PEEP selection

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital, School of Medicine, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
2. undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset

Exclusion Criteria:

1. age <18 years old
2. patient undergoing legal protection
3. contra-indications to EIT (e. g. severe chest trauma or wounds)
4. pneumothorax
5. patient undergoing ECMO
6. pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EIT-PEEP strategy; PEEP selected by EIT which remained at 15 min	Device: PEEP selection; Electric impedance tomography-guided PEEP titration
Experimental: Low FiO2-PEEP strategy; PEEP selected by low FiO2-PEEP table which remained at 15 min	Device: PEEP selection; Electric impedance tomography-guided PEEP titration
Experimental: High FiO2-PEEP strategy; PEEP selected by high FiO2-PEEP table which remained at 15 min	Device: PEEP selection; Electric impedance tomography-guided PEEP titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP	EIT-PEEP was obtained by EIT, low-PEEP was obtained by low FIO2-PEEP table, and high-PEEP was obtained by high FIO2-PEEP table.	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP	COV was obtained by EIT monitoring	up to 24 hours
Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP	dead space was obtained by EIT monitoring	up to 24 hours
Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP	shunt was obtained by EIT monitoring	up to 24 hours
Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP	wasted ventilation was obtained by EIT monitoring	up to 24 hours
Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP	wasted perfusion was obtained by EIT monitoring	up to 24 hours
ventilation distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP	ventilation distribution was obtained by EIT in difference regions	up to 24 hours
perfusion distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP	perfusion distribution was obtained by EIT in difference regions	up to 24 hours
Correlations between ventilation-perfusion mismatch and overdistension and lung collapses	Overdistension (%) and lung collapses (%) will be assessed by EIT. These two values cannot be measured separately. V/Q mismatch will be computed by EIT, and expressed in %. Correlation will be performed by linear regression.	up to 24 hours
recruitment-to-inflation (R/I) ratio	recruitment-to-inflation (R/I) ratio was computed between the two PEEP levels	up to 24 hours
PaO2/FIO2	PaO2/FIO2 was obtained by gas analysis	up to 24 hours
respiratory system mechanics	respiratory system compliance included lung compliance, chest wall compliance, and respiratory system compliance. respiratory system resistance will be computed as the inverse of compliance.	up to 24 hours
Correlation between V/Q mismatch markers and recruitability	Recruitability will be assessed between 15 and 5 cmH2O by respiratory mechanics, as the recruited volumes value (in mL). R/I ratio will be derived from these data (no unit). V/Q mismatch will be computed by EIT, and expressed in %. Correlation will be performed by linear regression.	up to 24 hours

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: liu ling, phD, Zhongda Hospital, School of Medicine, Southeast University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 1, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: EIT-PEEPstudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No