Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia

NCT ID: NCT01504893

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 984 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-09-30

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).

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Protective

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

Group Type: EXPERIMENTAL

Protective one lung ventilation

Intervention Type: PROCEDURE

Low tidal volume, PEEP and alveolar recruitment maneuver

Conventional

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Protective one lung ventilation

Low tidal volume, PEEP and alveolar recruitment maneuver

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera S. Maria della Misericordia

OTHER

Sponsor Role: lead

Responsible Party

Giorgio Della Rocca

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giorgio Della Rocca, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria S. Maria della Misericordia - Udine. Italy

Locations

ASST Papa Giovanni XXIII

Bergamo, , Italy

IRCCS Policlinico Sant'Orsola-Malpighi

Bologna, , Italy

Ospedale Centrale

Bolzano, , Italy

Azienda Ospedaliera Brotzu - Ospedale Oncologico Businco

Cagliari, , Italy

IRCCS Ospedale Policlinico San Martino

Genova, , Italy

Fondazione IRCCS Istituto Nazionale Tumori

Milan, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

Azienda Ospedaliera-Universitaria

Modena, , Italy

Istituto Nazionale Tumori Fondazione Pascale

Napoli, , Italy

Azienda Ospedaliero-Universitaria

Padua, , Italy

IRCCS Centro di Riferimento Oncologico della Basilicata

Rionero in Vulture, , Italy

Istituto Nazionale Tumori Regina Elena

Rome, , Italy

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Ospedale di Cattinara

Trieste, , Italy

Department of Anesthesia and Intensive Care Unit

Udine, , Italy

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 20829341 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19317902 (View on PubMed)

Other Identifiers

ALI01

Identifier Type: -

Identifier Source: org_study_id