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

NCT01272700 | Completed DMC

• 1 other identifier: 4-2010-0201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniation of Lumbar Vertebral Disc

Outcome Measures

Primary Outcomes (1)

• peak airway pressure

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

  30 minutes after prone position

Study Arms (2)

PCV

EXPERIMENTAL

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

Procedure: volume control

VCV

ACTIVE COMPARATOR

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

Procedure: pressure control

Interventions

volume control PROCEDURE

Volume controlled ventilation of tidal volume 10 ml/kg

PCV

pressure control PROCEDURE

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

VCV

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for lumbar spine surgery under general anaesthesia

You may not qualify if:

• Patients with coronary artery occlusive disease
• morbid obesity (body mass index ≥ 30 kg/m2)
• cerebrovascular disease and major obstructive or restrictive pulmonary disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

KR (1)