Clinical trial NCT01504893: Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
Official title: Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: One lung ventilation
PEEP
thoracic surgery
lobectomy and pneumonectomy
ARDS
Lead sponsor: Azienda Ospedaliera S. Maria della Misericordia
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 984
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* ASA IV
* Elective thoracotomies or thoracoscopic major lung resection surgery (lobectomy, bilobectomy, pneumonectomy)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acute Respiratory Distress Syndrome (ARDS) incidence
timeFrame: Hospital stay (7 days average expected)
Secondary outcomes:
measure: Postoperative pulmonary complications (PPCs)
timeFrame: Hospital stay (7 days average expected)
measure: In-hospital mortality
timeFrame: Hospital stay (7 days average aspected)
measure: Postoperative complications
timeFrame: Hospital stay (7 days average expected)
measure: Unplanned Intensive Care Unit (ICU) admission
timeFrame: Hospital stay (7 days average aspected)
measure: Intensive Care Unit (ICU) Length of stay
timeFrame: Hospital stay (7 days average aspected)
measure: Length of hospital stay
timeFrame: Hospital stay (7 days average expected)
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Bologna
country: Italy
facility: IRCCS Policlinico Sant'Orsola-Malpighi
city: Bolzano
country: Italy
facility: Ospedale Centrale
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Brotzu - Ospedale Oncologico Businco
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliera-Universitaria
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Padova
country: Italy
facility: Azienda Ospedaliero-Universitaria
city: Rionero In Vulture
country: Italy
facility: IRCCS Centro di Riferimento Oncologico della Basilicata
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Trieste
country: Italy
facility: Ospedale di Cattinara
city: Udine
country: Italy
facility: Department of Anesthesia and Intensive Care Unit
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
Study officials:
affiliation: Azienda Ospedaliero-Universitaria S. Maria della Misericordia - Udine. Italy
name: Giorgio Della Rocca, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang M, Ahn HJ, Kim K, Kim JA, Yi CA, Kim MJ, Kim HJ. Does a protective ventilation strategy reduce the risk of pulmonary complications after lung cancer surgery?: a randomized controlled trial. Chest. 2011 Mar;139(3):530-537. doi: 10.1378/chest.09-2293. Epub 2010 Sep 9.
citation: Licker M, Diaper J, Villiger Y, Spiliopoulos A, Licker V, Robert J, Tschopp JM. Impact of intraoperative lung-protective interventions in patients undergoing lung cancer surgery. Crit Care. 2009;13(2):R41. doi: 10.1186/cc7762. Epub 2009 Mar 24.