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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01191606
First received: August 5, 2010
Last updated: August 30, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Arterial Oxygenation During Protective One Lung Ventilation
Procedure: the change of ventilatory mode
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation for Thoracic Surgery

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • arterial oxygenation differences [ Time Frame: four time points during operation ] [ Designated as safety issue: Yes ]
    (1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.


Secondary Outcome Measures:
  • peak inspiratory pressure (Ppeak) [ Time Frame: four time points during operation ] [ Designated as safety issue: No ]
    (1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.

  • mean inspiratory pressure (Pmean) [ Time Frame: four time points during operation ] [ Designated as safety issue: No ]
    (1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.

  • plateau inspiratory pressure (Pplateau) [ Time Frame: four time points during operation ] [ Designated as safety issue: No ]
    (1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.


Estimated Enrollment: 34
Study Start Date: June 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
the exchange of ventilatory mode from volume controlled ventilation to pressure controlled ventilation
Procedure: 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.
Other Name: VCV-PCV group
Active Comparator: Group B
the exchange of ventilatory mode from pressure controlled ventilation to volume controlled ventilation
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.
Other Name: PCV-VCV group

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191606

Contacts
Contact: Jin Young Hwang, MD 82-31-787-7508 mistyblue15@naver.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jin Young Hwang, MD    82-31-787-7508    mistyblue15@naver.com   
Principal Investigator: Jin Young Hwang, MD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Jin Young Hwang, MD Fellow
  More Information

No publications provided

Responsible Party: Fellow, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01191606     History of Changes
Other Study ID Numbers: B-1005-100-003
Study First Received: August 5, 2010
Last Updated: August 30, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Bundang Hospital:
pressure controlled
volume controlled
arterial oxygenation
one lung ventilation

ClinicalTrials.gov processed this record on August 19, 2014