NCT03693365

Brief Summary

Fluid responsiveness is difficult to assess at the bedside. The accuracy of published techniques to detect preload-dependent patients have many pitfalls and limitations. The present study test the role of noninvasive effective pulmonary blood flow measured by expired carbon dioxide to detect fluid responsivess in mechanically ventilated patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 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

September 5, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2022

Completed
Last Updated

August 26, 2022

Status Verified

April 1, 2022

Enrollment Period

3.6 years

First QC Date

October 1, 2018

Last Update Submit

August 24, 2022

Conditions

Keywords

Carbon dioxidePulmonary blood flowVentilation

Outcome Measures

Primary Outcomes (1)

  • Fluid responsivess assessment with the effective pulmonary blood flow

    Comparison between standard method (pulse pressure variation) with a new method of fluid responsiveness (Effective pulmonary blood flow).

    10 months

Study Arms (1)

Patients undergoing surgeries

Patients undergoing surgery with general anesthesia and controlled mechanical ventilation with indication of invasive arterial blood pressure. Classification ASA 2-4

Procedure: PEEP trial

Interventions

PEEP trialPROCEDURE

Positive end-expiratory pressure (PEEP) is increased from 5 to 10 cmH2O during one minute.

Patients undergoing surgeries

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac and noncardiac surgery patients ASA 2-4

You may qualify if:

  • Written informed consent
  • Programmed cardiac and noncardiac surgeries
  • Need of invasive arterial blood pressure monitoring.

You may not qualify if:

  • Emergency surgeries.
  • Acute pulmonary diseases
  • Arrhytmias
  • Congestive cardiac failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Related Publications (1)

  • Tusman G, Groisman I, Maidana GA, Scandurra A, Arca JM, Bohm SH, Suarez-Sipmann F. The Sensitivity and Specificity of Pulmonary Carbon Dioxide Elimination for Noninvasive Assessment of Fluid Responsiveness. Anesth Analg. 2016 May;122(5):1404-11. doi: 10.1213/ANE.0000000000001047.

MeSH Terms

Conditions

Cardiovascular DiseasesRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gerardo Tusman, MD

    Hospital Privado de Comunidad de Mar del Plata

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

September 5, 2018

Primary Completion

April 1, 2022

Study Completion

April 12, 2022

Last Updated

August 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations