Back to resultsInflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy
Primary Purpose
Ventilator-Induced Lung Injury, Inflammatory Response, Respiratory Complication
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional One-Lung Ventilation
Protective One-lung ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator-Induced Lung Injury focused on measuring one-lung ventilation, broncho-alveolar lavage, protective ventilation, cytokines, thoracic surgery
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing elective lobectomy and wedge resection
Exclusion Criteria:
- emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conventional One-lung ventilation
Protective One-Lung Ventilation
Arm Description
The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)
The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)
Outcomes
Primary Outcome Measures
local cytokine inflammatory response in the two study groups
The levels of cytokines were evaluated in broncho-alveolar lavage (BAL)
Secondary Outcome Measures
incidence of postoperative respiratory in the two study groups
PaO2 /FIO 2 <300 mm Hg and /or the presence of newly developed lung lesions (lung infi ltration and atelectasis)
lenght of stay in the two study groups
lenght of hospital stay expressed in days
Full Information
NCT ID
NCT03056885
First Posted
February 12, 2017
Last Updated
February 14, 2017
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT03056885
Brief Title
Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy
Official Title
Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2, 2015 (Actual)
Primary Completion Date
November 25, 2015 (Actual)
Study Completion Date
January 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.
Detailed Description
One-lung ventilation (OLV) is a ventilation procedure used for pulmonary resection often causing lung injury. International guidelines have recommended for years the use of conventional ventilation (CV) with high tidal volume (VT) (8-10 ml\kg).A body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. In this study we compare the conventional strategy , consisted of Vt 10 mL/kg, with the protective strategy, consisted of Vt 5 mL/kg. Both Vt were based on predicted body weight (PBW). Broncho-alveolar lavages (BAL) are selectively performed in the dependent (ventilated) lung before and at the end of the OLV. The levels of pro-inflammatory (IL-1α, IL-1β, IL-6, IL-8, TNF) and anti-inflammatory (IL-2, IL-4, IL-10, INFγ) cytokines are evaluated. We also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Induced Lung Injury, Inflammatory Response, Respiratory Complication
Keywords
one-lung ventilation, broncho-alveolar lavage, protective ventilation, cytokines, thoracic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional One-lung ventilation
Arm Type
Experimental
Arm Description
The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)
Arm Title
Protective One-Lung Ventilation
Arm Type
Experimental
Arm Description
The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)
Intervention Type
Other
Intervention Name(s)
Conventional One-Lung Ventilation
Intervention Description
Vt 10 ml/kg
Intervention Type
Other
Intervention Name(s)
Protective One-lung ventilation
Intervention Description
Vt 5 ml/kg
Primary Outcome Measure Information:
Title
local cytokine inflammatory response in the two study groups
Description
The levels of cytokines were evaluated in broncho-alveolar lavage (BAL)
Time Frame
Change from Baseline cytokines level and the end of surgery (about 60 minutes)
Secondary Outcome Measure Information:
Title
incidence of postoperative respiratory in the two study groups
Description
PaO2 /FIO 2 <300 mm Hg and /or the presence of newly developed lung lesions (lung infi ltration and atelectasis)
Time Frame
within 48 hours of the operation
Title
lenght of stay in the two study groups
Description
lenght of hospital stay expressed in days
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing elective lobectomy and wedge resection
Exclusion Criteria:
emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy
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