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EIT in Patient Ventilator Asynchrony

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ClinicalTrials.gov Identifier: NCT04442815
Recruitment Status : Completed
First Posted : June 23, 2020
Last Update Posted : December 27, 2022
Information provided by (Responsible Party):
Chang-Wen Chen, National Cheng-Kung University Hospital

Brief Summary:
Patient-ventilator asynchrony is an important clinical issue in mechanically ventilated patients. For patients with moderate to severe acute respiratory distress syndrome (ARDS), various types of patient ventilator asynchrony may lead to injury of the lung. For example, double cycling may lead to high tidal volume and pendelluft may result in transient overstretch of dependent lung region. In this project, the investigators will record and analyze various types of patient-ventilator asynchrony in ARDS patients and analyze the regional distribution of lung gas and determined their harmful effect via concomitant recording of EIT and transpulmonary pressure. The results may influence our ventilator management of ARDS patients.

Condition or disease
ARDS, Human

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Study Type : Observational [Patient Registry]
Actual Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Analysis of Patient Ventilator Asynchrony Using Electrical Impedance Tomography (EIT) in Patients With Acute Respiratory Failure
Actual Study Start Date : December 13, 2019
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : May 31, 2021

Primary Outcome Measures :
  1. Patient ventilator asynchrony [ Time Frame: up to 1 hour following interruption of muscle relaxant ]
    Various types of patient ventilator asynchrony

  2. Regional ventilation distribution by EIT [ Time Frame: up to 1 hour following interruption of muscle relaxant ]
    Regional ventilation distribution by EIT in various types of patient ventilator asynchrony

Secondary Outcome Measures :
  1. hospitalization day and final outcome [ Time Frame: up to 3 months ]
    duration of hospitalization and hospital mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   all genders except pregnant woman
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
moderate to severe ARDS patients

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe ARDS

Exclusion Criteria:

  • Severe chronic obstructive pulmonary diseases
  • Proved barotrauma (including pneumothorax or pneumomediastinum etc.);
  • Pregnancy
  • Diseases characterized with increased intracranial pressure
  • Patients or family who refused the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442815

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Chang-Wen Chen
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
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Principal Investigator: Chang-Wen Chen, MD National Cheng-Kung University Hospital
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Responsible Party: Chang-Wen Chen, Associate professor and attending physician, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT04442815    
Other Study ID Numbers: EIT and ARF
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: December 27, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD may be shared once the data is published

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Chang-Wen Chen, National Cheng-Kung University Hospital:
ARDS, patient-ventilator interaction, EIT
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders