Pressure-Controlled vs Volume-Controlled Ventilation During One Lung Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by King Faisal University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
King Faisal University
ClinicalTrials.gov Identifier:
NCT00975468
First received: September 9, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

Compared with the information available in sepsis and trauma-associated ARDS, less is known about the cause and pattern of lung injury after thoracic surgery. Definition of lung injury in this context is difficult. Most now use the joint North American-European consensus conference definitions, but these are based only on gas exchange and radiology criteria. While gas exchange measures are reliable, thoracotomy inevitably causes radiological change and the interpretation of plain chest films becomes subjective. Definitions based on permeability and inflammatory changes would improve diagnosis, but are not routinely available in most units.

Pressure-controlled volume (PCV) may be useful to improve gas exchange and alveolar recruitment with associated lower airway pressures and shunt fraction during one-lung ventilation (OLV).

However, a recent prospective randomized study of the effects of PCV during OLV did not lead to improved oxygenation during OLV compared with VCV, but PCV did lead to lower peak airway pressures. To date, there are no reports of the effects of PCV versus VCV during OLV on the acute lung injury (ALI) after thoracotomy.


Condition Intervention Phase
Thoracic Surgery
Other: Pressure Controlled vs. Volume Controlled Ventilation during OLV
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study of the Effects of Pressure-controlled vs. Volume-controlled Ventilation During One Lung Ventilation on Lung Injury After Thoracotomy

Further study details as provided by King Faisal University:

Primary Outcome Measures:
  • Determine changes in the serum levels of cytokines [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Arterial blood gases, chest X- ray, pulmonary function tests, samples collection [serum and BAL] and laboratory testing for cytokine changes, the times of ventilation, extubation, ICU and hospital stay, mortality and morbidity. [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pressure-Controlled Ventilation
The patients' lungs ventilation will be initiated with a peak airway pressure that provided a tidal volume of 8 ml.kg-1. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.
Other: Pressure Controlled vs. Volume Controlled Ventilation during OLV
Ventilation will be initiated with a tidal volume of 8 ml.kg-1 in Volume-controlled group and with a peak airway pressure that provided a tidal volume of 8 ml.kg-1 in pressure-controlled group. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.
Placebo Comparator: Volume Controlled Ventilation
The patients' lungs will ventilated with a tidal volume of 8 ml.kg-1. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.
Other: Pressure Controlled vs. Volume Controlled Ventilation during OLV
Ventilation will be initiated with a tidal volume of 8 ml.kg-1 in Volume-controlled group and with a peak airway pressure that provided a tidal volume of 8 ml.kg-1 in pressure-controlled group. R.R will be adjusted to achieve an arterial PaCO2 4.5-6 kPa and FiO2 will be increased to 1.0 during OLV.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-60 years (ASA physical status II-III) scheduled for elective open thoracic surgery using one lung ventilation for periods longer than 1.5 h

Exclusion Criteria:

We will exclude the patients with:

  • decompensated cardiac (>New York Heart Association II)
  • pulmonary diseases (VC or FEV1<50% of the predicted values)
  • pulmonary hypertension (mean pulmonary artery pressure [MPAP] >30 mm Hg)
  • previous lobectomy or bilobectomy in the medical history
  • those treated with immune modulators (cytostatic drugs, corticosteroids and non-steroidal anti-inflammatory drugs, vaccination, blood products), within 3 months before surgery and with symptoms of an acute inflammatory process (clinically defined or abnormal data for C-reactive protein, leukocyte count, or body temperature)
  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: NCT00975468

Contacts
Contact: Mohamed Regal, M.D +96638966666 ext 114 mohamedregal@yahoo.com

Locations
Saudi Arabia
King Fahd Hospital of the University Recruiting
Al Khubar, Eastern, Saudi Arabia
Contact: Mohamed Regal, MD    +96638966666 ext 114    mohamedregal@yahoo.com   
Sponsors and Collaborators
King Faisal University
Investigators
Study Director: Mohamed Regal, M.D King Faisal University
  More Information

No publications provided

Responsible Party: Mohamed Regal, King Faisal University
ClinicalTrials.gov Identifier: NCT00975468     History of Changes
Other Study ID Numbers: PCV vs. VCV during OLV, +966508491257
Study First Received: September 9, 2009
Last Updated: June 21, 2011
Health Authority: Saudi Arabia: King Faisal University, Ad Dammam

Keywords provided by King Faisal University:
pressure-controlled
volume-controlled
one lung
ventilation
lung injury
thoracotomy

ClinicalTrials.gov processed this record on October 21, 2014