NCT04081142

Brief Summary

This study is an observational study. Investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-EIT method in the critically ill patients in ICU

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

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

May 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

2.3 years

First QC Date

September 3, 2019

Last Update Submit

December 18, 2020

Conditions

Keywords

EIT, pulmonary perfusion

Outcome Measures

Primary Outcomes (2)

  • Lung regional perfusion

    Lung regional perfusion monitored by EIT with saline

    Hour 1

  • oxygenation

    oxygenation(SpO2) measured by bedside monitor

    Hour 1

Study Arms (2)

acute respiratory failure group

acute respiratory failure (ARF) group: arterial oxygen partial pressure to fractional inspired oxygen ratio, PaO2/FiO2\<300 mmHg and/or peripheral oxygen saturation SaO2\<94% under air condition and/or severe dyspnea with respiratory rate \>30bpm.

control group

postoperative ICU patients without ARF were included

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients within 7days, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for clinical requirment were eligible for the study.

You may qualify if:

  • Time of admission ICU \< 7days
  • Age (\> 18 years old)
  • Have been placed central venous catheter based on clinical requirement

You may not qualify if:

  • Chest skin injured and cannot be monitored by EIT.
  • Severe Hypernatremia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

  • Wang Q, Su L, Jiang J, Wang N, He H, Long Y. Incorporating electrical impedance tomography to transpulmonary pressure-guided PEEP in severe ARDS with pneumothorax and multiple cavitations: a case report. Front Med (Lausanne). 2023 Aug 28;10:1240321. doi: 10.3389/fmed.2023.1240321. eCollection 2023.

  • He H, Chi Y, Long Y, Yuan S, Zhang R, Yang Y, Frerichs I, Moller K, Fu F, Zhao Z. Three broad classifications of acute respiratory failure etiologies based on regional ventilation and perfusion by electrical impedance tomography: a hypothesis-generating study. Ann Intensive Care. 2021 Aug 28;11(1):134. doi: 10.1186/s13613-021-00921-6.

MeSH Terms

Conditions

Respiratory InsufficiencyHypoxiaRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases

Study Officials

  • Yun Long

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
the director of the intensive care medicine

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 9, 2019

Study Start

May 1, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Locations