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

Primary Purpose

Surgery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Volume controlled ventilation
Pressure-controlled ventilation
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring surgery, transsphenoidal surgery, pituitary adenoma, mechanical ventilation, bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Volume controlled ventilation

Pressure-controlled ventilation

Arm 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.

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

Outcomes

Primary Outcome Measures

intraoperative bleeding
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
mean ventilatory plateau pressure during surgery
realisation of predefined objectives of minute ventilation
time spent with the predefined objectives of minute ventilation
changes of ventilation mode
number of changes of ventilation mode
arterial desaturation
number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery
recruitment maneuver
number of recruitment maneuver
duration of the surgical procedure
duration from surgical incision to end of the surgical procedure
endocrine healing
return to a low level of the abnormal endocrin abnormalities

Full Information

First Posted
June 29, 2013
Last Updated
October 28, 2016
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT01891838
Brief Title
Mode of Ventilation and Bleeding During Transsphenoidal Surgery
Acronym
Vent-Hyp
Official Title
Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
surgery, transsphenoidal surgery, pituitary adenoma, mechanical ventilation, bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volume controlled ventilation
Arm Type
Active Comparator
Arm 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.
Arm Title
Pressure-controlled ventilation
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Volume controlled ventilation
Intervention Type
Procedure
Intervention Name(s)
Pressure-controlled ventilation
Primary Outcome Measure Information:
Title
intraoperative bleeding
Description
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.
Time Frame
1 hour postoperatively
Secondary Outcome Measure Information:
Title
generated plateau pressures
Description
mean ventilatory plateau pressure during surgery
Time Frame
one hour after surgery
Title
realisation of predefined objectives of minute ventilation
Description
time spent with the predefined objectives of minute ventilation
Time Frame
one hour after surgery
Title
changes of ventilation mode
Description
number of changes of ventilation mode
Time Frame
one hour after surgery
Title
arterial desaturation
Description
number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery
Time Frame
one hour after surgery
Title
recruitment maneuver
Description
number of recruitment maneuver
Time Frame
one hour after surgery
Title
duration of the surgical procedure
Description
duration from surgical incision to end of the surgical procedure
Time Frame
one hour after surgery
Title
endocrine healing
Description
return to a low level of the abnormal endocrin abnormalities
Time Frame
three months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morgan Le Guen, MD
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31567997
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.
Results Reference
derived

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Mode of Ventilation and Bleeding During Transsphenoidal Surgery

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