Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

February 14, 2017 updated by: Mohsen Ibrahim, University of Roma La Sapienza

Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline cytokines level and the end of surgery (about 60 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 48 hours of the operation
lenght of stay in the two study groups
Time Frame: 1 month
lenght of hospital stay expressed in days
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2015

Primary Completion (Actual)

November 25, 2015

Study Completion (Actual)

January 15, 2016

Study Registration Dates

First Submitted

February 12, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3722/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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