NCT05873647

Brief Summary

Electrical impedance tomography was used to monitor changes in pulmonary perfusion distribution and V/Q ratio before and after iNO in patients with acute respiratory distress syndrome to investigate the factors predicting iNO reactivity and the physiological mechanism underlying changes in oxygenation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 10, 2023

Last Update Submit

May 15, 2023

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • Lung ventilation/perfusion ration

    Lung ventilation/perfusion ration after iNO assessed by EIT

    3 hours

Secondary Outcomes (8)

  • Lung perfusion distribution

    30minutes and 3 hours

  • Shunting

    30minutes and 3 hours

  • Dead space

    30minutes and 3 hours

  • Oxygenation index

    30minutes and 3 hours

  • Arterial partial pressure of carbon dioxide (PaCO2)

    30minutes and 3 hours

  • +3 more secondary outcomes

Eligibility Criteria

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

Patients with ARDS

You may qualify if:

  • Patients aged ≥ 18 years;
  • Patients are intubated and mechanically ventilated.

You may not qualify if:

  • EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
  • With a history of cerebral hemorrhage in the past half year, as well as bleeding in any site of the body;
  • Pneumothorax;
  • Medium or massive pleural effusion;
  • Refractory shock;
  • Pregnant
  • With chronic kidney disease
  • Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
  • Failure to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongling Zhang

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaojing Zou, prof.

CONTACT

+862785351606249126734@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 24, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

CN(1)