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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04535115

Acronym

TIDALEC

Enrollment

160

Registered

2020-09-01

Start date

2020-11-15

Completion date

2021-07-17

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Challenge, Hemodynamic Monitoring

Keywords

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

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.

Interventions

PROCEDUREStarting LRM (Lung Recruitment Maneuver)

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).

PROCEDUREStarting VtC (Tidal Volume Challenge)

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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 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
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 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
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 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
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	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
Number of complications in pneumothorax	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026