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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00975468
Recruitment Status : Suspended (Financial shortages due to lack of funderx)
First Posted : September 11, 2009
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
King Faisal University

Brief Summary:

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 or disease Intervention/treatment Phase
Thoracic Surgery Other: Pressure Controlled vs. Volume Controlled Ventilation during OLV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2023

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Determine changes in the serum levels of cytokines [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975468


Locations
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Saudi Arabia
King Fahd Hospital of the University
Dammam, Eastern, Saudi Arabia
Sponsors and Collaborators
King Faisal University
Investigators
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Study Director: Mohamed Regal, M.D King Faisal University
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Responsible Party: King Faisal University
ClinicalTrials.gov Identifier: NCT00975468    
Other Study ID Numbers: PCV vs. VCV during OLV
+966508491257
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King Faisal University:
pressure-controlled
volume-controlled
one lung
ventilation
lung injury
thoracotomy
Additional relevant MeSH terms:
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Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries