NCT04442815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

June 18, 2020

Last Update Submit

December 23, 2022

Conditions

Keywords

ARDS, patient-ventilator interaction, EIT

Outcome Measures

Primary Outcomes (2)

  • Patient ventilator asynchrony

    Various types of patient ventilator asynchrony

    up to 1 hour following interruption of muscle relaxant

  • Regional ventilation distribution by EIT

    Regional ventilation distribution by EIT in various types of patient ventilator asynchrony

    up to 1 hour following interruption of muscle relaxant

Secondary Outcomes (1)

  • hospitalization day and final outcome

    up to 3 months

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsall genders except pregnant woman
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

moderate to severe ARDS patients

You may qualify if:

  • Clinical diagnosis of moderate to severe ARDS

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-Wen Chen

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Chang-Wen Chen, MD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor and attending physician

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 23, 2020

Study Start

December 13, 2019

Primary Completion

January 31, 2021

Study Completion

May 31, 2021

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations