Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

Not Applicable

Completed

• Conditions: Inflammatory Response; Ventilator-Induced Lung Injury; Respiratory Complication
• Interventions: Other: Conventional One-Lung Ventilation; Other: Protective One-lung ventilation

• Registration Number: NCT03056885
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-11-02
• Primary Completion: 2015-11-25
• Study Completion: 2016-01-15
• Status Verified: 2017-02
• Study First Submitted: 2017-02-12
• Study First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-14
• Study First Posted: 2017-02-17
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
local cytokine inflammatory response in the two study groups	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

Name	Time	Method
incidence of postoperative respiratory in the two study groups	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	1 month	lenght of hospital stay expressed in days