Mode of Ventilation and Bleeding During Transsphenoidal Surgery (Vent-Hyp)

H

Hopital Foch

Status

Completed

Conditions

Surgery

Treatments

Procedure: Volume controlled ventilation
Procedure: Pressure-controlled ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT01891838
2012-A00397-36 (Other Identifier)
2012/15

Details and patient eligibility

About

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.

Full 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%.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

101 participants in 2 patient groups

Volume controlled ventilation
Active Comparator group
Description:
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.
Treatment:
Procedure: Volume controlled ventilation
Pressure-controlled ventilation
Experimental group
Description:
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
Treatment:
Procedure: Pressure-controlled ventilation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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