Effect of Electric Impedance Tomography-Guided PEEP Titration

Sponsor
Southeast University, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05736185
Collaborator
(none)
70
1
3
23
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PEEP selection
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Electric Impedance Tomography-Guided PEEP Titration on the Ventilation-perfusion Mismatch in Moderate or Severe ARDS
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    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

  1. difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    COV was obtained by EIT monitoring

  2. Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    dead space was obtained by EIT monitoring

  3. Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    shunt was obtained by EIT monitoring

  4. Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    wasted ventilation was obtained by EIT monitoring

  5. Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    wasted perfusion was obtained by EIT monitoring

  6. ventilation distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    ventilation distribution was obtained by EIT in difference regions

  7. perfusion distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP [up to 24 hours]

    perfusion distribution was obtained by EIT in difference regions

  8. Correlations between ventilation-perfusion mismatch and overdistension and lung collapses [up to 24 hours]

    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.

  9. recruitment-to-inflation (R/I) ratio [up to 24 hours]

    recruitment-to-inflation (R/I) ratio was computed between the two PEEP levels

  10. PaO2/FIO2 [up to 24 hours]

    PaO2/FIO2 was obtained by gas analysis

  11. respiratory system mechanics [up to 24 hours]

    respiratory system compliance included lung compliance, chest wall compliance, and respiratory system compliance. respiratory system resistance will be computed as the inverse of compliance.

  12. Correlation between V/Q mismatch markers and recruitability [up to 24 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongda Hospital, School of Medicine, Southeast University Nanjing Jiangsu China 210009

Sponsors and Collaborators

  • Southeast University, China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ling Liu, Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Southeast University, China
ClinicalTrials.gov Identifier:
NCT05736185
Other Study ID Numbers:
  • EIT-PEEPstudy
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023