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OpenTrials
Completed

NCT Number: NCT03056885

Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

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.

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Key information

Conditions

Ventilator-Induced Lung Injury Inflammatory Response Lung Diseases Lung Injury Respiratory Complication Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional One-Lung Ventilation

Other

Vt 10 ml/kg

Protective One-lung ventilation

Other

Vt 5 ml/kg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 17, 2017
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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