Clinical Trial: Mode of Ventilation and Bleeding During Transsphenoidal Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative 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 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.
- 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%.
Sponsor: Hopital Foch
Current Primary Outcome: intraoperative bleeding [ Time Frame: 1 hour postoperatively ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- generated plateau pressures [ Time Frame: one hour after surgery ]mean ventilatory plateau pressure during surgery
- realisation of predefined objectives of minute ventilation [ Time Frame: one hour after surgery ]time spent with the predefined objectives of minute ventilation
- changes of ventilation mode [ Time Frame: one hour after surgery ]number of changes of ventilation mode
- arterial desaturation [ Time Frame: one hour after surgery ]number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery
- recruitment maneuver [ Time Frame: one hour after surgery ]number of recruitment maneuver
- duration of the surgical procedure [ Time Frame: one hour after surgery ]duration from surgical incision to end of the surgical procedure
- endocrine healing [ Time Frame: three months after surgery ]return to a low level of the abnormal endocrin abnormalities
Original Secondary Outcome: Same as current
Information By: Hopital Foch
Dates:
Date Received: June 29, 2013
Date Started: June 2013
Date Completion:
Last Updated: October 28, 2016
Last Verified: October 2016