Surgery
Conditions
Keywords
surgery, transsphenoidal surgery, pituitary adenoma, mechanical ventilation, bleeding
Brief summary
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.
Detailed description
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. * group 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. * group Pressure-controlled ventilation: 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. * In both groups, the fraction of inspired oxygen is 50%. A recruitment maneuver is performed if the blood oxygen saturation became less than 92%.
Interventions
PROCEDUREVolume controlled ventilation
PROCEDUREPressure-controlled ventilation
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged \> 18 years * Patients scheduled for transsphenoidal surgery for pituitary adenomas
Exclusion criteria
* Pregnancy * Obesity (BMI\> 35) * Known respiratory disease * Redo surgery * Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative bleeding | 1 hour postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| realisation of predefined objectives of minute ventilation | one hour after surgery | time spent with the predefined objectives of minute ventilation |
| changes of ventilation mode | one hour after surgery | number of changes of ventilation mode |
| arterial desaturation | one hour after surgery | number of episodes of arterial desaturation (SpO2 \<92%) and lower arterial saturation during surgery |
| generated plateau pressures | one hour after surgery | mean ventilatory plateau pressure during surgery |
| duration of the surgical procedure | one hour after surgery | duration from surgical incision to end of the surgical procedure |
| endocrine healing | three months after surgery | return to a low level of the abnormal endocrin abnormalities |
| recruitment maneuver | one hour after surgery | number of recruitment maneuver |
Countries
France
Outcome results
None listed