NCT01891838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

June 29, 2013

Last Update Submit

October 28, 2016

Conditions

Surgery

Keywords

surgerytranssphenoidal surgerypituitary adenomamechanical ventilationbleeding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • generated plateau pressures

    one hour after surgery

  • realisation of predefined objectives of minute ventilation

    one hour after surgery

  • changes of ventilation mode

    one hour after surgery

  • arterial desaturation

    one hour after surgery

  • recruitment maneuver

    one hour after surgery

  • +2 more secondary outcomes

Study Arms (2)

Volume controlled ventilation

ACTIVE COMPARATOR

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

Pressure-controlled ventilation

EXPERIMENTAL

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

Interventions

Volume controlled ventilationPROCEDURE
Volume controlled ventilation
Pressure-controlled ventilationPROCEDURE
Pressure-controlled ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged \> 18 years
  • Patients scheduled for transsphenoidal surgery for pituitary adenomas

You may not qualify if:

  • Pregnancy
  • Obesity (BMI\> 35)
  • Known respiratory disease
  • Redo surgery
  • Preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (1)

  • 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.

    PMID: 31567997DERIVED

MeSH Terms

Conditions

Pituitary NeoplasmsHemorrhage

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Morgan Le Guen, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2013

First Posted

July 3, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(1)