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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01891838
First received: June 29, 2013
Last updated: October 28, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Surgery Procedure: Volume controlled ventilation Procedure: Pressure-controlled ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Care Provider)
Primary Purpose: Treatment
Official Title: Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 101
Study Start Date: June 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Volume controlled ventilation
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.
Procedure: Volume controlled ventilation
Experimental: 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
Procedure: Pressure-controlled ventilation

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891838

Locations
France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hôpital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01891838     History of Changes
Other Study ID Numbers: 2012/15
2012-A00397-36 ( Other Identifier: ANSM )
Study First Received: June 29, 2013
Last Updated: October 28, 2016

Keywords provided by Hopital Foch:
surgery
transsphenoidal surgery
pituitary adenoma
mechanical ventilation
bleeding

Additional relevant MeSH terms:
Hemorrhage
Pituitary Neoplasms
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 25, 2017