We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01272700
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Herniation of Lumbar Vertebral Disc Procedure: volume control Procedure: pressure control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. peak airway pressure [ Time Frame: 30 minutes after prone position ]
    Record peak airway pressure on anesthesia mechanical ventilator after anesthesia induction and 30 minutes after prone positioning.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272700


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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01272700     History of Changes
Other Study ID Numbers: 4-2010-0201
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012