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

This study is currently recruiting participants.
Verified January 2014 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01891838
First received: June 29, 2013
Last updated: January 7, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    mean ventilatory plateau pressure during surgery

  • realisation of predefined objectives of minute ventilation [ Time Frame: one hour after surgery ] [ Designated as safety issue: No ]
    time spent with the predefined objectives of minute ventilation

  • changes of ventilation mode [ Time Frame: one hour after surgery ] [ Designated as safety issue: No ]
    number of changes of ventilation mode

  • arterial desaturation [ Time Frame: one hour after surgery ] [ Designated as safety issue: No ]
    number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery

  • recruitment maneuver [ Time Frame: one hour after surgery ] [ Designated as safety issue: No ]
    number of recruitment maneuver

  • duration of the surgical procedure [ Time Frame: one hour after surgery ] [ Designated as safety issue: No ]
    duration from surgical incision to end of the surgical procedure

  • endocrine healing [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    return to a low level of the abnormal endocrin abnormalities


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891838

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Marc Fischler, MD    46252442 ext 00331    m.fischler@hopital-foch.org   
Principal Investigator: Morgan Le Guen, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hôpital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01891838     History of Changes
Other Study ID Numbers: 2012/15
Study First Received: June 29, 2013
Last Updated: January 7, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Pituitary Neoplasms
Hemorrhage
Blood Loss, Surgical
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
Intraoperative Complications

ClinicalTrials.gov processed this record on April 17, 2014