Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial

Cardiovascular Diseases Clinical Trial

Official title:

The Reliability of Noninvasive Effective Pulmonary Blood Flow to Detect Fluid Responsiveness During a Positive End-expirator Trial in Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693365
• Other study ID #: 291917072018
• Status: Completed
• Start date: September 5, 2018
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2022
• Source: Hospital Privado de Comunidad de Mar del Plata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective and observational study designed to test the accuracy of the non-invasive effective pulmonary blood flow measured by the capnodynamic methodology for detect preload-dependent patients.

Fourty patients undergoing mechanical ventilation during surgery will be studied. Preload-depency (fluid responsiveness) will be tested during an increase in end-expiratory pressure (PEEP) from 5 to 10 cmH2O during one minute. Pulse pressure variation will be use as the reference method to detect preload-dependency. The effective pulmonary blood flow will be continuously recorded during the PEEP maneuver. Receiver Operator Curves will be used to detect fluid responsiveness taking a pulse pressure variation higher than 13%.The corresponding cut off value for the effective pulmonary blood flow signal will be determined..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 12, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Programmed cardiac and noncardiac surgeries

• Need of invasive arterial blood pressure monitoring.

Exclusion Criteria:

• Emergency surgeries.

• Acute pulmonary diseases

• Arrhytmias

• Congestive cardiac failure

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Privado de Comunidad	Mar del Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

References & 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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