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Effect of Electric Impedance Tomography-Guided PEEP Titration

Primary Purpose

ARDS, Human

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEEP selection
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ARDS, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O) undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset Exclusion Criteria: age <18 years old patient undergoing legal protection contra-indications to EIT (e. g. severe chest trauma or wounds) pneumothorax patient undergoing ECMO pregnancy

Sites / Locations

  • Zhongda Hospital, School of Medicine, Southeast University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

EIT-PEEP strategy

Low FiO2-PEEP strategy

High FiO2-PEEP strategy

Arm Description

PEEP selected by EIT which remained at 15 min

PEEP selected by low FiO2-PEEP table which remained at 15 min

PEEP selected by high FiO2-PEEP table which remained at 15 min

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP
COV was obtained by EIT monitoring
Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
dead space was obtained by EIT monitoring
Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
shunt was obtained by EIT monitoring
Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
wasted ventilation was obtained by EIT monitoring
Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
wasted perfusion was obtained by EIT monitoring
ventilation distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
ventilation distribution was obtained by EIT in difference regions
perfusion distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
perfusion distribution was obtained by EIT in difference regions
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.
recruitment-to-inflation (R/I) ratio
recruitment-to-inflation (R/I) ratio was computed between the two PEEP levels
PaO2/FIO2
PaO2/FIO2 was obtained by gas analysis
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.
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.

Full Information

First Posted
February 9, 2023
Last Updated
September 17, 2023
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05736185
Brief Title
Effect of Electric Impedance Tomography-Guided PEEP Titration
Official Title
Effect of Electric Impedance Tomography-Guided PEEP Titration on the Ventilation-perfusion Mismatch in Moderate or Severe ARDS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
September 10, 2023 (Actual)
Study Completion Date
September 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EIT-PEEP strategy
Arm Type
Experimental
Arm Description
PEEP selected by EIT which remained at 15 min
Arm Title
Low FiO2-PEEP strategy
Arm Type
Experimental
Arm Description
PEEP selected by low FiO2-PEEP table which remained at 15 min
Arm Title
High FiO2-PEEP strategy
Arm Type
Experimental
Arm Description
PEEP selected by high FiO2-PEEP table which remained at 15 min
Intervention Type
Device
Intervention Name(s)
PEEP selection
Intervention Description
Electric impedance tomography-guided PEEP titration
Primary Outcome Measure Information:
Title
Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP
Description
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.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP
Description
COV was obtained by EIT monitoring
Time Frame
up to 24 hours
Title
Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Description
dead space was obtained by EIT monitoring
Time Frame
up to 24 hours
Title
Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Description
shunt was obtained by EIT monitoring
Time Frame
up to 24 hours
Title
Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Description
wasted ventilation was obtained by EIT monitoring
Time Frame
up to 24 hours
Title
Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Description
wasted perfusion was obtained by EIT monitoring
Time Frame
up to 24 hours
Title
ventilation distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Description
ventilation distribution was obtained by EIT in difference regions
Time Frame
up to 24 hours
Title
perfusion distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
Description
perfusion distribution was obtained by EIT in difference regions
Time Frame
up to 24 hours
Title
Correlations between ventilation-perfusion mismatch and overdistension and lung collapses
Description
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.
Time Frame
up to 24 hours
Title
recruitment-to-inflation (R/I) ratio
Description
recruitment-to-inflation (R/I) ratio was computed between the two PEEP levels
Time Frame
up to 24 hours
Title
PaO2/FIO2
Description
PaO2/FIO2 was obtained by gas analysis
Time Frame
up to 24 hours
Title
respiratory system mechanics
Description
respiratory system compliance included lung compliance, chest wall compliance, and respiratory system compliance. respiratory system resistance will be computed as the inverse of compliance.
Time Frame
up to 24 hours
Title
Correlation between V/Q mismatch markers and recruitability
Description
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.
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O) undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset Exclusion Criteria: age <18 years old patient undergoing legal protection contra-indications to EIT (e. g. severe chest trauma or wounds) pneumothorax patient undergoing ECMO pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liu ling, phD
Organizational Affiliation
Zhongda Hospital, School of Medicine, Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital, School of Medicine, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Electric Impedance Tomography-Guided PEEP Titration

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