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Clinical Trials/NCT01891838
NCT01891838
Completed
Not Applicable

Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding

Hopital Foch1 site in 1 country101 target enrollmentJune 2013
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Hopital Foch
Enrollment
101
Locations
1
Primary Endpoint
intraoperative bleeding
Status
Completed
Last Updated
9 years ago

Overview

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%.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
March 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • recruitment maneuver(one hour after surgery)
  • generated plateau pressures(one hour after surgery)
  • changes of ventilation mode(one hour after surgery)
  • arterial desaturation(one hour after surgery)
  • realisation of predefined objectives of minute ventilation(one hour after surgery)
  • duration of the surgical procedure(one hour after surgery)
  • endocrine healing(three months after surgery)

Study Sites (1)

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