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

Primary Purpose

Herniation of Lumbar Vertebral Disc

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

volume control

pressure control

About this trial

This is an interventional supportive care trial for Herniation of Lumbar Vertebral Disc

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCV

VCV

Arm Description

Peak airway pressure were set to deliver a tidal volume of 10 ml/kg of ideal body weight

After anesthetic induction, anesthesia maching were set to deliver a tidal volume of 10 ml/kg of ideal body weight

Outcomes

Primary Outcome Measures

peak airway pressure

Record peak airway pressure on anesthesia mechanical ventilator after anesthesia induction and 30 minutes after prone positioning.

Secondary Outcome Measures

Full Information

NCT ID

NCT01272700

First Posted

January 7, 2011

Last Updated

February 2, 2012

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01272700

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herniation of Lumbar Vertebral Disc

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PCV

Arm Type

Experimental

Arm Description

Peak airway pressure were set to deliver a tidal volume of 10 ml/kg of ideal body weight

Arm Title

VCV

Arm Type

Active Comparator

Arm Description

After anesthetic induction, anesthesia maching were set to deliver a tidal volume of 10 ml/kg of ideal body weight

Intervention Type

Procedure

Intervention Name(s)

volume control

Intervention Description

Volume controlled ventilation of tidal volume 10 ml/kg

Intervention Type

Procedure

Intervention Name(s)

pressure control

Intervention Description

Pressure controlled ventilation for peak airway pressure to deliver tidal volume 10 ml/kg.

Primary Outcome Measure Information:

Title

peak airway pressure

Description

Record peak airway pressure on anesthesia mechanical ventilator after anesthesia induction and 30 minutes after prone positioning.

Time Frame

30 minutes after prone position

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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