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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504893
• Other study ID #: ALI01
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2017

Study information

• Verified date: November 2022
• Source: Azienda Ospedaliera S. Maria della Misericordia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 984
• Est. completion date: September 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Protective one lung ventilation
Low tidal volume, PEEP and alveolar recruitment maneuver

Locations

Country	Name	City	State
Italy	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera S. Maria della Misericordia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Respiratory Distress Syndrome (ARDS) incidence	incidence of ARDS (%)	Hospital stay (7 days average expected)
Secondary	Postoperative pulmonary complications (PPCs)	Incidence of PPCs (%)	Hospital stay (7 days average expected)
Secondary	In-hospital mortality	To determine mortality (%)	Hospital stay (7 days average aspected)
Secondary	Postoperative complications	To determine how many patients (%) would have any postoperative complications	Hospital stay (7 days average expected)
Secondary	Unplanned Intensive Care Unit (ICU) admission	To determine how many patients would require an ICU admission (%)	Hospital stay (7 days average aspected)
Secondary	Intensive Care Unit (ICU) Length of stay	Length of stay in ICU (days)	Hospital stay (7 days average aspected)
Secondary	Length of hospital stay	Duration of hospital length of stay	Hospital stay (7 days average expected)