Tidal Volume Challenge and Lung Recruitment Maneuver (TIDALREC): the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness. (TIDALEC)

University Hospital, Lille

Status: Completed

Conditions: Hemodynamic Monitoring; Fluid Challenge

Treatments: Procedure: Starting LRM (Lung Recruitment Maneuver); Procedure: Starting VtC (Tidal Volume Challenge)

Study type: Interventional

Funder types: Other

Identifiers

NCT04535115

2020-A01460-39 (Other Identifier)

2019_71

Details and patient eligibility

About

In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge (VtC) and the Lung Recruitment Maneuver (LRM).

The objective is to determine whether the variation of 2 parameters such as pulse pression variation (PPV) and stroke volume variation (SVV) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. All patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. The order of the ventilation strategies will be determined by randomization.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of SVV and PPV with placement of a radial arterial catheter connected to the ProAQT® System.
• Block duration > 2 hours.

Exclusion criteria

• open surgery
• history of supra ventricular arrhythmias
• beta-blocking patient
• BMI>30 kg.m-2 or <15 kg.min-2
• right ventricular dysfunction
• severe valvulopathies
• intracardiac shunt
• renal failure dialysis
• patient's refusal

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Group 1

Experimental group

Description:

Starting LRM (Lung Recruitment Maneuver)

Treatment:

Procedure: Starting LRM (Lung Recruitment Maneuver)

Group 2

Experimental group

Description:

Starting VtC (Tidal Volume Challenge)

Treatment:

Procedure: Starting VtC (Tidal Volume Challenge)