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NCT Number: NCT05736185

Effect of Electric Impedance Tomography-Guided PEEP Titration

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.

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Key information

Conditions

ARDS, Human Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP selection

Device

Electric impedance tomography-guided PEEP titration

Primary outcomes

  1. Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP

    Time frame: 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 outcomes

  1. difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: up to 24 hours

    perfusion distribution was obtained by EIT in difference regions

  8. Correlations between ventilation-perfusion mismatch and overdistension and lung collapses

    Time frame: 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

    Time frame: up to 24 hours

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

  10. PaO2/FIO2

    Time frame: up to 24 hours

    PaO2/FIO2 was obtained by gas analysis

  11. respiratory system mechanics

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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