- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04081142
Application of Indicator Based-electrical Impedance Tomography Method Assess Lung Regional Perfusion in ICU Patients
December 18, 2020 updated by: Yun Long
Application of Indicator Based-EIT Method Assess Lung Regional Perfusion for Critically Ill Patients in ICU
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
Study Overview
Status
Completed
Conditions
Detailed Description
- Written informed consent was obtained from all patients or next of kin before data were included in the study.
- When the research team was available, adult patients within 1w, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for resuscitation were eligible for the study.
- Information collected at enrollment included demographic characteristics such as age, sex, Acute Physiology and Chronic Health Evaluation II score (APCHEII); . The global hemodynamic, respiration condition and PaO2 were measured. At the same time, the lung regional ventilation and perfusion assessed by the indicator based-EIT method(injection 10%NaCL).
- The 10%NaCL was injected by the central venous catheter.
Study Type
Observational
Enrollment (Actual)
119
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital, Chinese Academy of Medical Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- Time of admission ICU < 7days
- Age (> 18 years old)
- Have been placed central venous catheter based on clinical requirement
Exclusion Criteria:
.Chest skin injured and cannot be monitored by EIT.
- Severe Hypernatremia
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung regional perfusion
Time Frame: Hour 1
|
Lung regional perfusion monitored by EIT with saline
|
Hour 1
|
oxygenation
Time Frame: Hour 1
|
oxygenation(SpO2) measured by bedside monitor
|
Hour 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yun Long, Peking Union Medical College Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
July 31, 2020
Study Registration Dates
First Submitted
September 3, 2019
First Submitted That Met QC Criteria
September 4, 2019
First Posted (Actual)
September 9, 2019
Study Record Updates
Last Update Posted (Actual)
December 21, 2020
Last Update Submitted That Met QC Criteria
December 18, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIT-lung Perfusion in ICU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Failure
-
Poitiers University HospitalRecruitingAcute Respiratory Failure | Hypoxemic Respiratory FailureFrance
-
Catholic University of the Sacred HeartFisher and Paykel HealthcareCompletedWeaning Failure | Acute Respiratory FailureFrance, Greece, Italy, Spain
-
Hemovent GmbHMAXIS Medical, LLCActive, not recruitingRespiratory Failure | Cardiac Failure | Cardio-Respiratory FailureGermany
-
UPECLIN HC FM Botucatu UnespUnknownExtubation Failure | Acute Respiratory Failure Post ExtubationBrazil
-
Hospital Clinic of BarcelonaCompletedHypercapnic Respiratory Failure | Hypoxemic Respiratory FailureSpain
-
Efficacy Care R&D LtdMemorial Hermann Hospital; CRG Medical, Inc.UnknownShock | Shock, Septic | Respiratory Failure | Respiratory Distress Syndrome | Shock, Cardiogenic | Acute Cardiac Failure | Acute Respiratory Failure | Acute Kidney Failure | Multi Organ Failure | Respiratory Arrest | Acute Respiratory Failure With Hypoxia | Acute Respiratory Failure Requiring Reintubation | Acute... and other conditionsUnited States
-
University Hospital, AngersNot yet recruitingCardio-Respiratory FailureFrance
-
University Hospital, MotolCompletedRefractory Respiratory FailureCzechia
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedDevelopment of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery RoomNeonatal Respiratory FailureTurkey
-
Siriraj HospitalRecruitingAcute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory FailureThailand