Mode of Ventilation and Bleeding During Transsphenoidal Surgery
- Conditions
- Surgery
- Interventions
- Procedure: Pressure-controlled ventilationProcedure: Volume controlled ventilation
- Registration Number
- NCT01891838
- Lead Sponsor
- Hopital Foch
- 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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Aged > 18 years
- Patients scheduled for transsphenoidal surgery for pituitary adenomas
- Pregnancy
- Obesity (BMI> 35)
- Known respiratory disease
- Redo surgery
- Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pressure-controlled ventilation 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 Volume controlled ventilation Volume controlled ventilation 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method recruitment maneuver one hour after surgery number of recruitment maneuver
generated plateau pressures one hour after surgery mean ventilatory plateau pressure during surgery
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
realisation of predefined objectives of minute ventilation one hour after surgery time spent with the predefined objectives of minute ventilation
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
Trial Locations
- Locations (1)
Hopital Foch
🇫🇷Suresnes, France