Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03056885
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
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.

Layout table for study information
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

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Layout table for additonal information
Responsible Party: Mohsen Ibrahim, Medical Director, University of Roma La Sapienza
ClinicalTrials.gov 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

Layout table for additional information
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
cytokines
thoracic surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries