The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01272700
First received: January 7, 2011
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

Prone position in spinal surgery can increase airway pressure and decrease dynamic lung compliance by a frame used for postural stabilization. Also, it can increase hemodynamic instability such as reduced blood pressure by aggravating cardiac index.

Former study shows pressure controlled ventilation on the pulmonary mechanics can improve alveolar use and oxygenation than volume controlled ventilation. The latter one means controlling a patient's breathing completely through tidal volume and set breathing rate. This could be useful for the patients not possible to breath by themselves because it guarantees the perfect breathing.

The pressure controlled ventilation is used when there is a possibility to change a patient's environment. The pressure will be maintained steadily, but volume and flux will be changed. That means through the pressure already set, the whole breathing will be maintained from the beginning to end. If a patient's resistance is increased, the volume will be decreased even though the way of blood pressure control is same. However, the tidal volume per minute can be controlled somewhat and barotrauma can be decreased by controlling respiratory rate. Through this study, we are expecting the pressure controlled ventilation in prone position can improve lung mechanics and oxygenation.


Condition Intervention
Herniation of Lumbar Vertebral Disc
Procedure: volume control
Procedure: pressure control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • peak airway pressure [ Time Frame: 30 minutes after prone position ] [ Designated as safety issue: No ]
    Record peak airway pressure on anesthesia mechanical ventilator after anesthesia induction and 30 minutes after prone positioning.


Enrollment: 40
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCV
Peak airway pressure were set to deliver a tidal volume of 10 ml/kg of ideal body weight
Procedure: volume control
Volume controlled ventilation of tidal volume 10 ml/kg
Active Comparator: VCV
After anesthetic induction, anesthesia maching were set to deliver a tidal volume of 10 ml/kg of ideal body weight
Procedure: pressure control
Pressure controlled ventilation for peak airway pressure to deliver tidal volume 10 ml/kg.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for lumbar spine surgery under general anaesthesia

Exclusion Criteria:

  • Patients with coronary artery occlusive disease
  • morbid obesity (body mass index ≥ 30 kg/m2)
  • cerebrovascular disease and major obstructive or restrictive pulmonary disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01272700

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01272700     History of Changes
Other Study ID Numbers: 4-2010-0201
Study First Received: January 7, 2011
Last Updated: February 2, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on September 18, 2014