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

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: PEEP trial

• Registration Number: NCT03693365
• Lead Sponsor: Hospital Privado de Comunidad de Mar del Plata

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.

Detailed 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..

Study Timeline

• Study Start: 2018-09-05
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-12
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing surgeries	PEEP trial	Patients undergoing surgery with general anesthesia and controlled mechanical ventilation with indication of invasive arterial blood pressure. Classification ASA 2-4

Primary Outcome Measures

Name	Time	Method
Fluid responsivess assessment with the effective pulmonary blood flow	10 months	Comparison between standard method (pulse pressure variation) with a new method of fluid responsiveness (Effective pulmonary blood flow).

Trial Locations

Locations (1)

Hospital Privado de Comunidad; 🇦🇷 Mar del Plata, Buenos Aires, Argentina