Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

NCT ID: NCT03056885

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-02
• Study Completion Date: 2016-01-15

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.

Conditions

Ventilator-Induced Lung Injury; Inflammatory Response; Respiratory Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional One-lung ventilation

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

Group Type: EXPERIMENTAL

Conventional One-Lung Ventilation

Intervention Type: OTHER

Vt 10 ml/kg

Protective One-Lung Ventilation

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

Group Type: EXPERIMENTAL

Protective One-lung ventilation

Intervention Type: OTHER

Vt 5 ml/kg

Interventions

Conventional One-Lung Ventilation

Vt 10 ml/kg

Intervention Type: OTHER

Protective One-lung ventilation

Vt 5 ml/kg

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Mohsen Ibrahim

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3722/2015

Identifier Type: -

Identifier Source: org_study_id