An interventional study of Protective one lung ventilation in Acute Respiratory Distress Syndrome, sponsored by Azienda Ospedaliera S. Maria della Misericordia. Completed at 16 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by Azienda Ospedaliera S. Maria della Misericordia · Not applicable, Interventional, and Prevention
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)
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).
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 984 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Azienda Ospedaliera S. Maria della Misericordia is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Procedure: Protective one lung ventilation
Two-lung ventilation (TLV): tidal volume = 8 mL / kg PBW, peak airway pressure ≤ 25 cmH2O; I: E = 1:2; after lung re-expansion to the closure of the chest PEEP set to 5 cmH2O OLV (OLV): 6 mL / kg PBW, peak airway pressure ≤ 35 cmH2O; I: E = 1:2.
Low tidal volume, PEEP and alveolar recruitment maneuver
Acute Respiratory Distress Syndrome (ARDS) incidence
incidence of ARDS (%)
Time frame: Hospital stay (7 days average expected)
Postoperative pulmonary complications (PPCs)
Incidence of PPCs (%)
Time frame: Hospital stay (7 days average expected)
In-hospital mortality
To determine mortality (%)
Time frame: Hospital stay (7 days average aspected)
Postoperative complications
To determine how many patients (%) would have any postoperative complications
Time frame: Hospital stay (7 days average expected)
Unplanned Intensive Care Unit (ICU) admission
To determine how many patients would require an ICU admission (%)
Time frame: Hospital stay (7 days average aspected)
Intensive Care Unit (ICU) Length of stay
Length of stay in ICU (days)
Time frame: Hospital stay (7 days average aspected)
Length of hospital stay
Duration of hospital length of stay
Time frame: Hospital stay (7 days average expected)
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Azienda Ospedaliera S. Maria della Misericordia