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Mode of Ventilation and Bleeding During Transsphenoidal Surgery

Not Applicable
Completed
Conditions
Surgery
Interventions
Procedure: Pressure-controlled ventilation
Procedure: 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
Inclusion Criteria
  • Aged > 18 years
  • Patients scheduled for transsphenoidal surgery for pituitary adenomas
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Exclusion Criteria
  • Pregnancy
  • Obesity (BMI> 35)
  • Known respiratory disease
  • Redo surgery
  • Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pressure-controlled ventilationPressure-controlled ventilationinitial 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 ventilationVolume controlled ventilationVolume 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
NameTimeMethod
intraoperative bleeding1 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
NameTimeMethod
recruitment maneuverone hour after surgery

number of recruitment maneuver

generated plateau pressuresone hour after surgery

mean ventilatory plateau pressure during surgery

changes of ventilation modeone hour after surgery

number of changes of ventilation mode

arterial desaturationone hour after surgery

number of episodes of arterial desaturation (SpO2 \<92%) and lower arterial saturation during surgery

realisation of predefined objectives of minute ventilationone hour after surgery

time spent with the predefined objectives of minute ventilation

duration of the surgical procedureone hour after surgery

duration from surgical incision to end of the surgical procedure

endocrine healingthree months after surgery

return to a low level of the abnormal endocrin abnormalities

Trial Locations

Locations (1)

Hopital Foch

🇫🇷

Suresnes, France

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