Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056885
• Other study ID #: 3722/2015
• Status: Completed
• Phase: N/A
• First received: February 12, 2017
• Last updated: February 14, 2017
• Start date: November 2, 2015
• Est. completion date: January 15, 2016

Study information

• Verified date: February 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 15, 2016
• Est. primary completion date: November 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Response
• Lung Injury
• Respiratory Complication
• Ventilator-Induced Lung Injury

Intervention

Other:
• Conventional One-Lung Ventilation
Vt 10 ml/kg
• Protective One-lung ventilation
Vt 5 ml/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local cytokine inflammatory response in the two study groups	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	incidence of postoperative respiratory in the two study groups	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
Secondary	lenght of stay in the two study groups	lenght of hospital stay expressed in days	1 month