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

NCT03498807 | Completed DMC

• 1 other identifier: 106094-E
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ARDS; Acute Respiratory Distress Syndrome

Keywords

ARDS; Acute Respiratory Distress Syndrome; PEEP; pressure-volume loop; Positive End-Expiratory Pressure; hysteresis

Outcome Measures

Primary Outcomes (1)

• Compare the survival rate between two groups

  Calculate the survival rate

  Compare the survival rate between two groups during 91 days in hospitalization

Secondary Outcomes (1)

• Oxygention improve rate in the hospital

  Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later

Study Arms (2)

Control group_Use Ventilator P/V tool

EXPERIMENTAL

Use the Pressure/Volume Loop

Device: Ventiltor P/V Loop

Study group_Use EIT

ACTIVE COMPARATOR

Use the Electrical Impedance Tomography

Device: Electrical Impedance Tomography

Interventions

Ventiltor P/V Loop DEVICE

determine the Optimal PEEP and keep 48hr on ARDS patients

Control group_Use Ventilator P/V tool

Electrical Impedance Tomography DEVICE

determine Optimal PEEP and keep 48hr on ARDS patients

Study group_Use EIT

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• On pacemaker
• Pregnant
• Thoracic or spinal cord trauma
• Pneumothorax
• Hemodynamic instability
• IICP

Sponsors & Collaborators

• Hui-Ju Hsu: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei County, Banqiao Dist, 22060, Taiwan

Location

Related Publications (3)

• 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 Xue. 2014 Nov;26(11):789-93. doi: 10.3760/cma.j.issn.2095-4352.2014.11.005. Chinese.

  PMID: 25399892 RESULT

• Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sanchez-Garcia M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/respcare.02068. Epub 2013 Jan 29.

  PMID: 23362167 RESULT

• 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. No abstract available.

  PMID: 28973075 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Hou T Chang, doctor

  Far Eastern Memorial Hospital

  STUDY DIRECTOR

• Ping H Wang, Bachelor

  Far Eastern Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During this period, all patients were total sedation using continuous infusion, to prevent any spontaneous breathing .All patients were ventilated using a ventilator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: respiratory therapist

Model Details: Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU.(P/F≦200+PEEP≧ 5cmH20)

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 17, 2018
• Study Start: April 13, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)