Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01504893
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2011-12-30
Brief Title:
Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
Sponsor:
Azienda Ospedaliera S Maria della Misericordia
Organization:
Azienda Ospedaliera S Maria della Misericordia
Study Overview
Official Title:
Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mlkg 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 11 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 lobectomypneumonectomy 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
International literature reports a wide use of tidal volume around 5-6 mlkg 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 11 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 lobectomypneumonectomy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None