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Mode of Ventilation and Bleeding During Transsphenoidal Surgery

NCT ID: NCT01891838

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-03-31

Brief Summary

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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

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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%.

Conditions

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Surgery

Keywords

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surgery transsphenoidal surgery pituitary adenoma mechanical ventilation bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Volume controlled ventilation

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Pressure-controlled ventilation

Intervention Type PROCEDURE

Interventions

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Volume controlled ventilation

Intervention Type PROCEDURE

Pressure-controlled ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morgan Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31567997 (View on PubMed)

Other Identifiers

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2012-A00397-36

Identifier Type: OTHER

Identifier Source: secondary_id

2012/15

Identifier Type: -

Identifier Source: org_study_id