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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01460-39 | Other Identifier | ID-RCB number,ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Starting LRM (Lung Recruitment Maneuver) |
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| Group 2 | Experimental | Starting VtC (Tidal Volume Challenge) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver. | 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 | throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Lebuffe, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Lille | 59037 | France |
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| 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). |
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| The AUCs of the two techniques calculated above. | 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 | 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). | 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 | 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. | 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 | 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 | Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2. | 1 day (at recovery room after surgery) and at day 2 |