Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

Overview

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.

Full Title of Study: “Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 25, 2015

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 mlkg).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.

Interventions

  • Other: Conventional One-Lung Ventilation
    • Vt 10 ml/kg
  • Other: Protective One-lung ventilation
    • Vt 5 ml/kg

Arms, Groups and Cohorts

  • Experimental: Conventional One-lung ventilation
    • The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)
  • Experimental: Protective One-Lung Ventilation
    • The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • lenght of stay in the two study groups
    • Time Frame: 1 month
    • lenght of hospital stay expressed in days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Roma La Sapienza
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohsen Ibrahim, Medical Director – University of Roma La Sapienza

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