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NCT Number: NCT01891838

Mode of Ventilation and Bleeding During Transsphenoidal Surgery

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.

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Key information

Conditions

Surgery Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hemorrhage Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

volume controlled ventilation

Procedure

pressure-controlled ventilation

Procedure

Primary outcomes

  1. intraoperative bleeding

    Time frame: 1 hour postoperatively

    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 outcomes

  1. generated plateau pressures

    Time frame: one hour after surgery

    mean ventilatory plateau pressure during surgery

  2. realisation of predefined objectives of minute ventilation

    Time frame: one hour after surgery

    time spent with the predefined objectives of minute ventilation

  3. changes of ventilation mode

    Time frame: one hour after surgery

    number of changes of ventilation mode

  4. arterial desaturation

    Time frame: one hour after surgery

    number of episodes of arterial desaturation (SpO2 <92%) and lower arterial saturation during surgery

  5. recruitment maneuver

    Time frame: one hour after surgery

    number of recruitment maneuver

  6. duration of the surgical procedure

    Time frame: one hour after surgery

    duration from surgical incision to end of the surgical procedure

  7. endocrine healing

    Time frame: three months after surgery

    return to a low level of the abnormal endocrin abnormalities

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Vent-Hyp

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2013
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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