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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Procedure: Volume controlled ventilation; 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%.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hopital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
generated plateau pressures	mean ventilatory plateau pressure during surgery	one hour after surgery
realisation of predefined objectives of minute ventilation	time spent with the predefined objectives of minute ventilation	one hour after surgery
changes of ventilation mode	number of changes of ventilation mode	one hour after surgery
arterial desaturation	number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery	one hour after surgery
recruitment maneuver	number of recruitment maneuver	one hour after surgery
duration of the surgical procedure	duration from surgical incision to end of the surgical procedure	one hour after surgery
endocrine healing	return to a low level of the abnormal endocrin abnormalities	three months after surgery

Collaborators and Investigators

• Sponsor: Hopital Foch

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 29, 2013
• First Submitted That Met QC Criteria: June 29, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: mechanical ventilation; surgery; bleeding; pituitary adenoma; transsphenoidal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2012/15; 2012-A00397-36 (Other Identifier: ANSM)