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Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

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. Identifier: NCT03056885
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
Mohsen Ibrahim, University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Ventilator-Induced Lung Injury Inflammatory Response Respiratory Complication Other: Conventional One-Lung Ventilation Other: Protective One-lung ventilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : November 25, 2015
Actual Study Completion Date : January 15, 2016

Arm Intervention/treatment
Experimental: Conventional One-lung ventilation
The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)
Other: Conventional One-Lung Ventilation
Vt 10 ml/kg

Experimental: Protective One-Lung Ventilation
The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)
Other: Protective One-lung ventilation
Vt 5 ml/kg

Primary Outcome Measures :
  1. local cytokine inflammatory response in the two study groups [ Time Frame: Change from Baseline cytokines level and the end of surgery (about 60 minutes) ]
    The levels of cytokines were evaluated in broncho-alveolar lavage (BAL)

Secondary Outcome Measures :
  1. incidence of postoperative respiratory in the two study groups [ Time Frame: within 48 hours of the operation ]
    PaO2 /FIO 2 <300 mm Hg and /or the presence of newly developed lung lesions (lung infi ltration and atelectasis)

  2. lenght of stay in the two study groups [ Time Frame: 1 month ]
    lenght of hospital stay expressed in days

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Mohsen Ibrahim, Medical Director, University of Roma La Sapienza Identifier: NCT03056885    
Other Study ID Numbers: 3722/2015
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Mohsen Ibrahim, University of Roma La Sapienza:
one-lung ventilation
broncho-alveolar lavage
protective ventilation
thoracic surgery
Additional relevant MeSH terms:
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Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries