NCT05408442

Brief Summary

The relationship between the presence or absence of endothelial dysfunction and changes in pulmonary perfusion will be evaluated, to then determine if there is any association between changes in the V / Q ratio and tolerance to the supine position after a prone cycle in patients with acute respiratory distress syndrome on mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

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

July 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

June 1, 2022

Last Update Submit

August 5, 2024

Conditions

ARDSMechanical VentilationProne Position

Outcome Measures

Primary Outcomes (1)

  • Tolerance to supine position

    It will be defined by changes in PaO2/FiO2 after position changes

    12 hours

Secondary Outcomes (5)

  • Endothelial dysfunction

    48 hours

  • V/Q changes

    48 hours

  • Endothelial dysfunction

    48 hours

  • Endothelial dysfunction

    48 hours

  • Endothelial dysfunction

    48 hours

Study Arms (1)

Prone

ARDS patients during mechanical ventilation in prone position

Other: No intervention

Interventions

No interventionOTHER

No intervention

Prone

Eligibility Criteria

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

Patients admitted in the ICU of Hospital Clínico Universidad Católica

You may qualify if:

  • Patients with a diagnosis of ARDS
  • Patients connected to IMV
  • Patients in prone position for less than 48 hours.

You may not qualify if:

  • Diagnosis of exacerbation of chronic lung disease or cardiogenic pulmonary edema.
  • Presence of contraindications for the use of the prone position and for the use of the EIT belt
  • Patient under 18 years of age
  • Pregnancy
  • Refusal of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universidad Católica

Santiago, Santiago Metropolitan, Santiago, Chile

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 7, 2022

Study Start

July 1, 2021

Primary Completion

June 1, 2022

Study Completion

December 31, 2022

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations

CL(1)