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Completed

NCT Number: NCT04535115

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

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.

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Key information

Conditions

Fluid Challenge Hemodynamic Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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 are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute

  2. The AUCs of the two techniques calculated above.

    Time frame: 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 are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute

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

    Time frame: 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 are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute

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

    Time frame: 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 are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute

  5. Number of complications in pneumothorax

    Time frame: 1 day (at recovery room after surgery) and at day 2

    Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Intraoperative Hemodynamic Optimization: Predictive Value to Fluid Respon-siveness of the Tidal Volume Challenge and the Lung Recruitment Maneuver by Monitoring the Variation of the Pulsed Pressure and the Variation of the Systolic Ejection Volume.

Acronym: TIDALEC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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