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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome

• 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).

Study Timeline

• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Study Start: 2013-09
• Primary Completion: 2016-08
• Study Completion: 2017-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 984

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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; 🇮🇹 Padova, Italy

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