Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

University of Roma La Sapienza

Status: Completed

Conditions: Respiratory Complication; Inflammatory Response; Ventilator-Induced Lung Injury

Treatments: Other: Protective One-lung ventilation; Other: Conventional One-Lung Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03056885

3722/2015

Details and patient eligibility

About

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 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Conventional One-lung ventilation

Experimental group

Description:

The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)

Treatment:

Other: Conventional One-Lung Ventilation

Protective One-Lung Ventilation

Experimental group

Description:

The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)

Treatment:

Other: Protective One-lung ventilation