Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation

NCT ID: NCT01191606

Last Updated: 2010-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-12-31

Brief Summary

The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

Detailed Description

One-lung ventilation (OLV) during thoracic surgery, in particular, video-assisted thoracic surgery is a standard practice to facilitate surgical exposure, but arterial hypoxemia has been a serious complication during one lung ventilation. Furthermore, recent studies have shown that one lung ventilation with a conventional tidal volume can involve lung injury associated with alveolar overdistension and high airway pressure. Therefore, lung protective ventilation with a low tidal volume during one lung ventilation has been suggested, and a recent study showed that protective ventilation during lung cancer surgery was associated with improved postoperative respiratory outcomes such as reduced incidence of acute lung injury and atelectasis.

During protective one lung ventilation limiting airway pressure and using low tidal volume, it is important to provide uniform alveolar expansion and maintain adequate oxygenation. A previous study suggested that the decelerating inspiratory flow delivery used in pressure controlled ventilation improved ventilation/perfusion distribution and arterial oxygenation during one lung ventilation5. Moreover, according to a recent study during laparoscopic obesity surgery, pressure-controlled ventilation improved oxygenation compared with volume controlled ventilation, which was associated with higher instantaneous flow peaks and a better alveolar recruitment6. On the other hand, other studies showed that ventilatory mode during one lung ventilation did not affect arterial oxygenation. However, these studies were performed during mechanical ventilation using conventional tidal volume, and the effect of ventilatory mode during protective one lung ventilation on oxygenation has not been clearly determined yet.The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

Conditions

Arterial Oxygenation During Protective One Lung Ventilation

Keywords

pressure controlled; volume controlled; arterial oxygenation; one lung ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A

the exchange of ventilatory mode from volume controlled ventilation to pressure controlled ventilation

Group Type: ACTIVE_COMPARATOR

the change of ventilatory mode

Intervention Type: PROCEDURE

One lung ventilation initiated with volume controlled ventilation(OLV-VCV) with an inspired oxygen fraction (FIO2) of 1.0, a tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to pressure controlled ventilation and the inspiratory pressure was adjusted to obtain the tidal volume 6 mL/kg. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.

Group B

the exchange of ventilatory mode from pressure controlled ventilation to volume controlled ventilation

Group Type: ACTIVE_COMPARATOR

the change of ventilatory mode

Intervention Type: PROCEDURE

One lung ventilation initiated with pressure controlled ventilation with an inspired oxygen fraction (FIO2) of 1.0, an inspiratory pressure provided the tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to VCV with a tidal volume 6 mL/kg based on PBW. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.

Interventions

the change of ventilatory mode

One lung ventilation initiated with volume controlled ventilation(OLV-VCV) with an inspired oxygen fraction (FIO2) of 1.0, a tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to pressure controlled ventilation and the inspiratory pressure was adjusted to obtain the tidal volume 6 mL/kg. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.

Intervention Type: PROCEDURE

the change of ventilatory mode

One lung ventilation initiated with pressure controlled ventilation with an inspired oxygen fraction (FIO2) of 1.0, an inspiratory pressure provided the tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to VCV with a tidal volume 6 mL/kg based on PBW. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.

Intervention Type: PROCEDURE

Other Intervention Names

VCV-PCV group; PCV-VCV group

Eligibility Criteria

Inclusion Criteria

• patients (ASA physical status I-III) undergoing elective thoracic surgery in the lateral position with at least 1 h of one lung ventilation

Exclusion Criteria

• patients with major organ dysfunction, hemodynamic instability, or increased intracranial pressure

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Bundang Hospital

Principal Investigators

Jin Young Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Fellow

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jin Young Hwang, MD

Role: CONTACT

Phone: 82-31-787-7508

Email: mistyblue15@naver.com

Facility Contacts

Jin Young Hwang, MD

Role: primary

Other Identifiers

B-1005-100-003

Identifier Type: -

Identifier Source: org_study_id