Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy

• ClinicalTrials.gov Identifier: NCT03056885
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: February 17, 2017
• Sponsor: University of Roma La Sapienza
• Information provided by (Responsible Party): Mohsen Ibrahim, University of Roma La Sapienza

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ventilator-Induced Lung Injury; Inflammatory Response; Respiratory Complication	Other: Conventional One-Lung Ventilation; Other: Protective One-lung ventilation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?
• Actual Study Start Date: November 2, 2015
• Actual Primary Completion Date: November 25, 2015
• Actual Study Completion Date: January 15, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Conventional One-lung ventilation; The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)	Other: Conventional One-Lung Ventilation; Vt 10 ml/kg
Experimental: Protective One-Lung Ventilation; The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)	Other: Protective One-lung ventilation; Vt 5 ml/kg

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Mohsen Ibrahim, Medical Director, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT03056885
• Other Study ID Numbers: 3722/2015
• First Posted: February 17, 2017
• Last Update Posted: February 17, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohsen Ibrahim, University of Roma La Sapienza:

one-lung ventilation; broncho-alveolar lavage; protective ventilation; cytokines; thoracic surgery

Additional relevant MeSH terms:

Lung Injury; Ventilator-Induced Lung Injury; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries