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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00397-36 | Other Identifier | ANSM |
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The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volume controlled ventilation | Active Comparator | Volume controlled ventilation: tidal volume of 7 mL/kg ideal body weight, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Ventilatory frequency is changed if necessary to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg. |
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| Pressure-controlled ventilation | Experimental | initial pressure of 15 cm H2O, frequency of 12 cycles/minute, I/E ratio of 1:2, no positive end expiratory pressure. Pressure is modified to maintain a tidal volume of 7 mL/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of CO2 between 35 and 40 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volume controlled ventilation | Procedure |
| ||
| Pressure-controlled ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative bleeding | intraoperative bleeding is estimated by the operator (always the same) as minimal (1), low (3), with no significant change in the conduct of the surgical procedure (5) with significant change in the conduct of surgical procedure (7). Intermediate levels are used to rate the levels of intermediate severity. | 1 hour postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| generated plateau pressures | mean ventilatory plateau pressure during surgery | one hour after surgery |
| realisation of predefined objectives of minute ventilation | time spent with the predefined objectives of minute ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Le Guen, MD | Hôpital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | 92150 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31567997 | Derived | Le Guen M, Paternot A, Declerck A, Feliot E, Gayat E, Gaillard S, Fischler M. Impact of the modality of mechanical ventilation on bleeding during pituitary surgery: A single blinded randomized trial. Medicine (Baltimore). 2019 Sep;98(38):e17254. doi: 10.1097/MD.0000000000017254. |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| Procedure |
|
| one hour after surgery |
| changes of ventilation mode | number of changes of ventilation mode | one hour after surgery |
| arterial desaturation | number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery | one hour after surgery |
| recruitment maneuver | number of recruitment maneuver | one hour after surgery |
| duration of the surgical procedure | duration from surgical incision to end of the surgical procedure | one hour after surgery |
| endocrine healing | return to a low level of the abnormal endocrin abnormalities | three months after surgery |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |