Effect of Electric Impedance Tomography-Guided PEEP Titration

ARDS, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736185
• Other study ID #: EIT-PEEPstudy
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: Southeast University, China
• Contact: liu ling, phD
• Phone: +8613851435472
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome

Intervention

Device:
• PEEP selection
Electric impedance tomography-guided PEEP titration

Locations

Country	Name	City	State
China	Zhongda Hospital, School of Medicine, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	difference in center of ventilation (COV) between EIT-PEEP, low-PEEP, and high PEEP	COV was obtained by EIT monitoring	up to 24 hours
Secondary	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
Secondary	Difference in shunt measured with EIT between EIT-PEEP, low-PEEP, and high PEEP	shunt was obtained by EIT monitoring	up to 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	recruitment-to-inflation (R/I) ratio	recruitment-to-inflation (R/I) ratio was computed between the two PEEP levels	up to 24 hours
Secondary	PaO2/FIO2	PaO2/FIO2 was obtained by gas analysis	up to 24 hours
Secondary	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
Secondary	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