NCT06254456

Brief Summary

To assess fluid responsiveness in prone patient

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Mar 2024

Longer than P75 for not_applicable

Status
not yet recruiting

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 Progress50%
Mar 2024Jul 2028

First Submitted

Initial submission to the registry

January 4, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2025

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2028

Expected
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

January 4, 2024

Last Update Submit

February 3, 2024

Conditions

Fluid Responsiveness

Keywords

Fluid responsiveness, prone, EEOT, TVC, ARDS

Outcome Measures

Primary Outcomes (1)

  • Pulse Pressure Variation

    Detect the pulse pressure variation from cardiac output monitoring ( A- line )

    1 year

Study Arms (1)

Prone patients

EXPERIMENTAL
Diagnostic Test: End expiratory occlusion test

Interventions

End expiratory occlusion testDIAGNOSTIC_TEST

Fluid responsiveness test

Also known as: Tidal volume challenges test
Prone patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients planed to prone position for treatment

You may not qualify if:

  • no consent
  • arrhythmia
  • pregnancy
  • pre existing pneumothorax
  • pre existing fluid overload
  • cannot insert arterial or central venous catheters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellowship Training in Critical Care Medicine

Study Record Dates

First Submitted

January 4, 2024

First Posted

February 12, 2024

Study Start

March 1, 2024

Primary Completion

May 4, 2025

Study Completion (Estimated)

July 4, 2028

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share