Mode of Ventilation and Bleeding During Transsphenoidal Surgery

Surgery Clinical Trial

— Vent-Hyp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891838
• Other study ID #: 2012/15
• Secondary ID: 2012-A00397-36
• Status: Completed
• Phase: N/A
• First received: June 29, 2013
• Last updated: October 28, 2016
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Pituitary Neoplasms
• Surgery

Intervention

Procedure:
• Volume controlled ventilation

• Pressure-controlled ventilation

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	generated plateau pressures	mean ventilatory plateau pressure during surgery	one hour after surgery	No
Secondary	realisation of predefined objectives of minute ventilation	time spent with the predefined objectives of minute ventilation	one hour after surgery	No
Secondary	changes of ventilation mode	number of changes of ventilation mode	one hour after surgery	No
Secondary	arterial desaturation	number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery	one hour after surgery	No
Secondary	recruitment maneuver	number of recruitment maneuver	one hour after surgery	No
Secondary	duration of the surgical procedure	duration from surgical incision to end of the surgical procedure	one hour after surgery	No
Secondary	endocrine healing	return to a low level of the abnormal endocrin abnormalities	three months after surgery	No