Clinical trial NCT05736185: 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
Overall status: COMPLETED
Phase: NA
Conditions: ARDS, Human
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in ventilation-perfusion mismatch between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
Secondary outcomes:
measure: difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
measure: Difference in dead space measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
measure: Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
measure: Difference in wasted ventilation measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
measure: Difference in wasted perfusion measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
measure: ventilation distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
measure: perfusion distribution measured with EIT between EIT-PEEP, low-PEEP, and high PEEP
timeFrame: up to 24 hours
measure: Correlations between ventilation-perfusion mismatch and overdistension and lung collapses
timeFrame: up to 24 hours
measure: recruitment-to-inflation (R/I) ratio
timeFrame: up to 24 hours
measure: PaO2/FIO2
timeFrame: up to 24 hours
measure: respiratory system mechanics
timeFrame: up to 24 hours
measure: Correlation between V/Q mismatch markers and recruitability
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, School of Medicine, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital, School of Medicine, Southeast University
name: liu ling, phD
role: STUDY_DIRECTOR
References: