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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 7, 2011
Last Updated Date	February 2, 2012
Start Date ^ICMJE	August 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 2, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01272700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation
Official Title ^ICMJE	The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Herniation of Lumbar Vertebral Disc
Intervention ^ICMJE	Procedure: volume control Volume controlled ventilation of tidal volume 10 ml/kg Procedure: pressure control Pressure controlled ventilation for peak airway pressure to deliver tidal volume 10 ml/kg.
Study Arm (s)	Experimental: PCV Peak airway pressure were set to deliver a tidal volume of 10 ml/kg of ideal body weight Intervention: Procedure: volume control Active Comparator: VCV After anesthetic induction, anesthesia maching were set to deliver a tidal volume of 10 ml/kg of ideal body weight Intervention: Procedure: pressure control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01272700
Other Study ID Numbers ^ICMJE	4-2010-0201
Has Data Monitoring Committee	Yes
Responsible Party	Yonsei University
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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