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Acute Respiratory Distress SyndromeNCT01504893

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

A study testing Protective one lung ventilation in people with Acute Respiratory Distress Syndrome, run by Azienda Ospedaliera S. Maria della Misericordia at 16 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
Protective one lung ventilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
984 participants
Where
16 sitesItaly
Study dates
Sep 2013to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • Pulmonary hypertension
  • Renal failure requiring dialytic treatment
  • Drug addiction
  • Mental retardation, depression and psychiatric disease
  • Motor or sensory deficit
  • Pregnancy

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • ASST Papa Giovanni XXIII

    Bergamo

  • IRCCS Policlinico Sant'Orsola-Malpighi

    Bologna

  • Ospedale Centrale

    Bolzano

  • Azienda Ospedaliera Brotzu - Ospedale Oncologico Businco

    Cagliari

  • IRCCS Ospedale Policlinico San Martino

    Genova

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan

  • IRCCS Ospedale San Raffaele

    Milan

  • Azienda Ospedaliera-Universitaria

    Modena

  • Istituto Nazionale Tumori Fondazione Pascale

    Naples

  • Azienda Ospedaliero-Universitaria

    Padova

  • IRCCS Centro di Riferimento Oncologico della Basilicata

    Rionero in Vulture

  • Istituto Nazionale Tumori Regina Elena

    Rome

  • Azienda Ospedaliera Universitaria Senese

    Siena

  • Ospedale di Cattinara

    Trieste

  • Department of Anesthesia and Intensive Care Unit

    Udine, 33100

  • Ospedale di Circolo e Fondazione Macchi

    Varese

Other trials in Italy

About this study

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

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)

Read the 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).

Being tested
Protective one lung ventilation
Keywords
One lung ventilation, PEEP, thoracic surgery, lobectomy and pneumonectomy, ARDS
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protective one lung ventilationProcedure or surgery

    Low tidal volume, PEEP and alveolar recruitment maneuver

Study groups in NCT01504893
Study groupRoleWhat they receive
ProtectiveExperimentalTwo-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
Receives: Procedure: Protective one lung ventilation
ConventionalNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Respiratory Distress Syndrome (ARDS) incidence

    incidence of ARDS (%)

    Measured: Hospital stay (7 days average expected)

Secondary outcomes (6)

  1. Postoperative pulmonary complications (PPCs)

    Incidence of PPCs (%)

    Measured: Hospital stay (7 days average expected)

  2. In-hospital mortality

    To determine mortality (%)

    Measured: Hospital stay (7 days average aspected)

  3. Postoperative complications

    To determine how many patients (%) would have any postoperative complications

    Measured: Hospital stay (7 days average expected)

  4. Unplanned Intensive Care Unit (ICU) admission

    To determine how many patients would require an ICU admission (%)

    Measured: Hospital stay (7 days average aspected)

  5. Intensive Care Unit (ICU) Length of stay

    Length of stay in ICU (days)

    Measured: Hospital stay (7 days average aspected)

  6. Length of hospital stay

    Duration of hospital length of stay

    Measured: Hospital stay (7 days average expected)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2012 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2016
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504893
Sponsor's protocol ID
ALI01
Status last verified
Nov 2022
First submitted
30 Dec 2011
Last updated
2 Dec 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20829341

  • 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.

    PubMed 19317902

Questions about this trial

What is this clinical trial studying?

A study testing Protective one lung ventilation in people with Acute Respiratory Distress Syndrome, run by Azienda Ospedaliera S. Maria della Misericordia at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Respiratory Distress Syndrome (ARDS) incidence (time frame: Hospital stay (7 days average expected)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01504893, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.

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