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

NCT04535115 | Completed

• 2 other identifiers: 2019_712020-A01460-39
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid Challenge; Hemodynamic Monitoring

Keywords

Tidal Volume Challenge; Lung Recruitment Maneuver; Pulse Pression Varia-tion; Stroke Volume Variation.; Fluid Responsiveness.

Outcome Measures

Primary Outcomes (1)

• The area under the ROC curve (AUC) of the variation of the pulsed pressure (VPP) during the tidal volume challenge (VtC).

  throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery

Secondary Outcomes (5)

• The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.

  throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery

• The AUCs of the two techniques calculated above.

  throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery

• The area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).

  throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery

• The area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.

  throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery

• Number of complications in pneumothorax

  1 day (at recovery room after surgery) and at day 2

Study Arms (2)

Group 1

EXPERIMENTAL

Starting LRM (Lung Recruitment Maneuver)

Procedure: Starting LRM (Lung Recruitment Maneuver)

Group 2

EXPERIMENTAL

Starting VtC (Tidal Volume Challenge)

Procedure: Starting VtC (Tidal Volume Challenge)

Interventions

Starting LRM (Lung Recruitment Maneuver) PROCEDURE

The LRM is performed first for 30 seconds (an insufflation pressure of 30 cmH2O for 30 seconds is applied). After a free interval of 3 minutes, the VtC is done during 1 minute. For VtC, tidal volume is increased from 6 to 8 ml.kg-1 of predicted body weight. Finally, after a new free interval of 3 minutes, the fluid challenge (consisting in fluid administration of 250 ml of Ringer Lactate) is started for 10 minutes (in aim to determine which patients are responders). This sequence is repeated every 30 minutes (maximum four times).

Group 1

Starting VtC (Tidal Volume Challenge) PROCEDURE

The VtC is performed first for 1 minute. After a free interval of 3 minutes, the LRM is done for 30 seconds. Finally, after another free interval of 3 minutes, the fluid challenge is started for 10 minutes. This sequence is repe-tead every 30 minutes (maximum four times).

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

Study Officials

• Gilles Lebuffe, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: November 15, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

FR (1)