A Comparison of Optimal PEEP Determination Guided by EIT and Conventional Protective Ventilation Tool in ARDS Patients

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

A Comparison of Optimal Positive End Expiratory Pressure Determination Guided by Electrical Impedance Tomography and Conventional Protective Ventilation Tool in Acute Respiratory Distress Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498807
• Other study ID #: 106094-E
• Status: Completed
• Phase: N/A
• Start date: April 13, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2019
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. In this study ,the investigators selected two best positive end-expiratory pressure(PEEP) assessment methods to compare:

First is using the conventional postive ventilator to choose positive end-expiratory pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, we utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far Eastern memorial hospital, Taiwan.

Description:

Acute respiratory distress syndrome (ARDS)，over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (PEEP), both can effectively reduce the mortality rate. And increase PEEP，the alveolar pressure is greater than the atmospheric pressure when exhaled，So that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse.

The study of PEEP in the setting mode has not yet been conclusive. Currently in the clinical situation，there are several ways to choose the best PEEP mode for ARDS patients. In this study the investigators selected two best PEEP assessment methods to compare:

First is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support in ICU at the Far Eastern memorial hospital, Taiwan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F? 200 with PEEP = 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)

Exclusion Criteria:

• On pacemaker

• Pregnant

• Thoracic or spinal cord trauma

• Pneumothorax

• Hemodynamic instability

• IICP

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• Ventiltor P/V Loop
determine the Optimal PEEP and keep 48hr on ARDS patients
• Electrical Impedance Tomography
determine Optimal PEEP and keep 48hr on ARDS patients

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei county	Banqiao Dist

Sponsors (1)

Lead Sponsor	Collaborator
Hui-Ju Hsu

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sánchez-García M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/res — View Citation

Sahetya SK, Brower RG. Lung Recruitment and Titrated PEEP in Moderate to Severe ARDS: Is the Door Closing on the Open Lung? JAMA. 2017 Oct 10;318(14):1327-1329. doi: 10.1001/jama.2017.13695. — View Citation

Xu L, Wang Z, Li T, Li Z, Hu X, Feng Q, Duan D, Gao X. [Comparison of extracorporeal membrane oxygenation and mechanical ventilation for inter-hospital transport of severe acute respiratory distress syndrome patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the survival rate between two groups	Calculate the survival rate	Compare the survival rate between two groups during 91 days in hospitalization
Secondary	Oxygention improve rate in the hospital	Calculate PaO2/FiO2 ratio improvement rate in the hospital	Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later