Inflammatory Response, Respiratory Complication, Ventilator-Induced Lung Injury
Conditions
Keywords
one-lung ventilation, broncho-alveolar lavage, protective ventilation, cytokines, thoracic surgery
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.
Interventions
OTHERConventional One-Lung Ventilation
Vt 10 ml/kg
OTHERProtective One-lung ventilation
Vt 5 ml/kg
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed