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 ]

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.


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