Status:
COMPLETED
Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
Lead Sponsor:
Azienda Ospedaliera S. Maria della Misericordia
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if a protective ventilatory strategy during one-lung ventilation (OLV) based on low tidal volume, PEEP and alveolar recruitment maneuver can reduce Acute Resp...
Detailed Description
Pulmonary postoperative complications (PPCs) are the most frequent adverse events after thoracic surgery. Acute respiratory distress syndrome (ARDS) is the most severe among PPCs. Injurious mechanical...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years
- ASA IV
- Elective thoracotomies or thoracoscopic major lung resection surgery (lobectomy, bilobectomy, pneumonectomy)
Exclusion
- Emergency surgery
- Wedge resection or atypical resection
- Non-resective lung surgery requiring OLV
- Patients \< 18 years
- BMI \< 20 and BMI \> 29
- Heart disease with ejection fraction \<50% and/or severe valvulopathy
- Pulmonary hypertension
- Renal failure requiring dialytic treatment
- Drug addiction
- Mental retardation, depression and psychiatric disease
- Motor or sensory deficit
- Pregnancy
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
984 Patients enrolled
Trial Details
Trial ID
NCT01504893
Start Date
September 1 2013
End Date
September 1 2017
Last Update
December 2 2022
Active Locations (16)
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1
ASST Papa Giovanni XXIII
Bergamo, Italy
2
IRCCS Policlinico Sant'Orsola-Malpighi
Bologna, Italy
3
Ospedale Centrale
Bolzano, Italy
4
Azienda Ospedaliera Brotzu - Ospedale Oncologico Businco
Cagliari, Italy