Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery
1 other identifier
interventional
984
1 country
16
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedDecember 2, 2022
November 1, 2022
2.9 years
December 30, 2011
November 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Respiratory Distress Syndrome (ARDS) incidence
incidence of ARDS (%)
Hospital stay (7 days average expected)
Secondary Outcomes (6)
Postoperative pulmonary complications (PPCs)
Hospital stay (7 days average expected)
In-hospital mortality
Hospital stay (7 days average aspected)
Postoperative complications
Hospital stay (7 days average expected)
Unplanned Intensive Care Unit (ICU) admission
Hospital stay (7 days average aspected)
Intensive Care Unit (ICU) Length of stay
Hospital stay (7 days average aspected)
- +1 more secondary outcomes
Study Arms (2)
Protective
EXPERIMENTALTwo-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
Conventional
NO INTERVENTIONTwo-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.
Interventions
Low tidal volume, PEEP and alveolar recruitment maneuver
Eligibility Criteria
You may qualify if:
- Patients ≥ 18 years
- ASA IV
- Elective thoracotomies or thoracoscopic major lung resection surgery (lobectomy, bilobectomy, pneumonectomy)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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, 33100, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Related Publications (2)
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.
PMID: 20829341BACKGROUNDLicker 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.
PMID: 19317902BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giorgio Della Rocca, MD, Prof
Azienda Ospedaliero-Universitaria S. Maria della Misericordia - Udine. Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
December 30, 2011
First Posted
January 6, 2012
Study Start
September 1, 2013
Primary Completion
August 1, 2016
Study Completion
September 1, 2017
Last Updated
December 2, 2022
Record last verified: 2022-11