Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Procedure: Protective one lung ventilation
- Registration Number
- NCT01504893
- Lead Sponsor
- Azienda Ospedaliera S. Maria della Misericordia
- 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 Respiratory Distress Syndrome (ARDS) and Postoperative pulmonary complications (PPCs) after major pulmonary resection.
Primary endpoint: Evaluation of postoperative ARDS incidence
Secondary endpoint: Evaluation od PPC incidence and postoperative outcomes (other complications, unplanned Intensive Care Admission, hospital and ICU length of stay, in-hospital mortality)
- 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 ventilation is a recognized risk factor associated with ARDS and PPCs after major thoracic surgery.
International literature reports a wide use of tidal volume around 5-6 ml/kg predicted body weight (PBW) during one lung ventilation (OLV) but variable use of PEEP and alveolar recruitment maneuver (ARM).
The aim of this multicenter, randomized, single blind study is to determine if a protective ventilatory strategy during OLV based on low tidal volume, PEEP and alveolar recruitment maneuver compared to conventional strategy can reduce ARDS and PPCs after major pulmonary resection.
Primary outcome is the incidence of in-hospital ARDS.
Secondary outcomes are in-hospital incidence of postoperative pulmonary complications (PPCs), major cardiovascular events, unplanned Intensive Care Unit admission, in-hospital length of stay and mortality
RANDOMIZATION
Patients are randomly assigned to receive protective or conventional OLV according to a computer-generated randomization list (1:1 ratio) before anesthesia induction.
Patients are blinded to the treatment. Anesthesiologists and surgeons are unblinded to the treatment during the surgical procedure and the postoperative outcome assessment.
MEASUREMENTS
Intraoperative collection of ventilatory settings, airway pressures, arterial blood gases analysis at the following time points:
T1: two lung ventilation in supine position before placing the patient in lateral decubitus; T2: 30 minutes after OLV start; T3: 60 minutes after OLV start; T4: 20 minutes after lobectomy/pneumonectomy (during OLV); T5: 15 minutes after ARM in supine position and during two lung ventilation.
Postoperative data collection 1, 12, 24, 36, 48 hours after surgery and at discharge. Arterial blood gas analysis will be performed 1 hour after extubation and 24 and 72 hours after surgery (or in case of respiratory insufficiency).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 984
- Patients ≥ 18 years
- ASA IV
- Elective thoracotomies or thoracoscopic major lung resection surgery (lobectomy, bilobectomy, pneumonectomy)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protective Protective one lung ventilation Two-lung ventilation (TLV): tidal volume = 8 mL / kg PBW, peak airway pressure ≤ 25 cm H2O, I: E = 1:2; after lung re-expansion to the closure of the chest will set a PEEP of 5 cmH2O OLV (OLV): 4 mL / kg PBW, peak airway pressure ≤ 35 cmH2O, respiratory rate \<30, I:E = 1:2 / 1:3. During OLV in case of desaturation (before increasing the FiO2) and every 60 minutes alveolar recruitment maneuvers followed by the setting of PEEP to 5 cmH2O
- Primary Outcome Measures
Name Time Method Acute Respiratory Distress Syndrome (ARDS) incidence Hospital stay (7 days average expected) incidence of ARDS (%)
- Secondary Outcome Measures
Name Time Method Postoperative pulmonary complications (PPCs) Hospital stay (7 days average expected) Incidence of PPCs (%)
In-hospital mortality Hospital stay (7 days average aspected) To determine mortality (%)
Postoperative complications Hospital stay (7 days average expected) To determine how many patients (%) would have any postoperative complications
Unplanned Intensive Care Unit (ICU) admission Hospital stay (7 days average aspected) To determine how many patients would require an ICU admission (%)
Intensive Care Unit (ICU) Length of stay Hospital stay (7 days average aspected) Length of stay in ICU (days)
Length of hospital stay Hospital stay (7 days average expected) Duration of hospital length of stay
Trial Locations
- Locations (16)
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Fondazione IRCCS Istituto Nazionale Tumori
🇮🇹Milan, Italy
Ospedale di Cattinara
🇮🇹Trieste, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Azienda Ospedaliera-Universitaria
🇮🇹Modena, Italy
IRCCS Centro di Riferimento Oncologico della Basilicata
🇮🇹Rionero In Vulture, Italy
IRCCS Policlinico Sant'Orsola-Malpighi
🇮🇹Bologna, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale Centrale
🇮🇹Bolzano, Italy
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Department of Anesthesia and Intensive Care Unit
🇮🇹Udine, Italy
Istituto Nazionale Tumori Regina Elena
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Azienda Ospedaliero-Universitaria
🇮🇹Padova, Italy
Azienda Ospedaliera Brotzu - Ospedale Oncologico Businco
🇮🇹Cagliari, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milan, Italy