Clinical trial NCT01891838: Mode of Ventilation and Bleeding During Transsphenoidal Surgery
Official title: Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: surgery
transsphenoidal surgery
pituitary adenoma
mechanical ventilation
bleeding
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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).

Primary outcomes:
measure: intraoperative bleeding
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: generated plateau pressures
timeFrame: one hour after surgery
measure: realisation of predefined objectives of minute ventilation
timeFrame: one hour after surgery
measure: changes of ventilation mode
timeFrame: one hour after surgery
measure: arterial desaturation
timeFrame: one hour after surgery
measure: recruitment maneuver
timeFrame: one hour after surgery
measure: duration of the surgical procedure
timeFrame: one hour after surgery
measure: endocrine healing
timeFrame: three months after surgery
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hôpital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Guen M, Paternot A, Declerck A, Feliot E, Gayat E, Gaillard S, Fischler M. Impact of the modality of mechanical ventilation on bleeding during pituitary surgery: A single blinded randomized trial. Medicine (Baltimore). 2019 Sep;98(38):e17254. doi: 10.1097/MD.0000000000017254.