Ventilator-Induced Lung InjuryNCT03056885
Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy
A study testing Conventional One-Lung Ventilation and Protective One-lung ventilation in people with Ventilator-Induced Lung Injury and Inflammatory Response, run by University of Roma La Sapienza.
Trial summary
This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Induced Lung Injury, Inflammatory Response, Respiratory Complication
- What is being tested?
- Conventional One-Lung Ventilation and Protective One-lung ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2015to 15 Jan 2016
- 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 undergoing elective lobectomy and wedge resection
Who cannot join
- emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV
About this study
Official title: Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?
This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.
Read the detailed description
One-lung ventilation (OLV) is a ventilation procedure used for pulmonary resection often causing lung injury. International guidelines have recommended for years the use of conventional ventilation (CV) with high tidal volume (VT) (8-10 ml\kg).A body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. In this study we compare the conventional strategy , consisted of Vt 10 mL/kg, with the protective strategy, consisted of Vt 5 mL/kg. Both Vt were based on predicted body weight (PBW). Broncho-alveolar lavages (BAL) are selectively performed in the dependent (ventilated) lung before and at the end of the OLV. The levels of pro-inflammatory (IL-1α, IL-1β, IL-6, IL-8, TNF) and anti-inflammatory (IL-2, IL-4, IL-10, INFγ) cytokines are evaluated. We also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.
- Being tested
- Conventional One-Lung Ventilation, Protective One-lung ventilation
- Keywords
- one-lung ventilation, broncho-alveolar lavage, protective ventilation, cytokines, thoracic surgery
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional One-Lung VentilationOther
Vt 10 ml/kg
Protective One-lung ventilationOther
Vt 5 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Conventional One-lung ventilation | Experimental | The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight) Receives: Other: Conventional One-Lung Ventilation |
| Protective One-Lung Ventilation | Experimental | The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight) Receives: Other: Protective One-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
local cytokine inflammatory response in the two study groups
The levels of cytokines were evaluated in broncho-alveolar lavage (BAL)
Measured: Change from Baseline cytokines level and the end of surgery (about 60 minutes)
Secondary outcomes (2)
incidence of postoperative respiratory in the two study groups
PaO2 /FIO 2 <300 mm Hg and /or the presence of newly developed lung lesions (lung infi ltration and atelectasis)
Measured: within 48 hours of the operation
lenght of stay in the two study groups
lenght of hospital stay expressed in days
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start2 Nov 2015
- Primary completion25 Nov 2015
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Ibrahim, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056885
- Sponsor's protocol ID
- 3722/2015
- Status last verified
- Feb 2017
- First submitted
- 12 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?
- ClinicalTrials.gov ID
- NCT03056885
- Acronym / sponsor ID
- 3722/2015
- Keywords
- one-lung ventilation, broncho-alveolar lavage, protective ventilation, cytokines, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.
Detailed description
One-lung ventilation (OLV) is a ventilation procedure used for pulmonary resection often causing lung injury. International guidelines have recommended for years the use of conventional ventilation (CV) with high tidal volume (VT) (8-10 ml\kg).A body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. In this study we compare the conventional strategy , consisted of Vt 10 mL/kg, with the protective strategy, consisted of Vt 5 mL/kg. Both Vt were based on predicted body weight (PBW). Broncho-alveolar lavages (BAL) are selectively performed in the dependent (ventilated) lung before and at the end of the OLV. The levels of pro-inflammatory (IL-1α, IL-1β, IL-6, IL-8, TNF) and anti-inflammatory (IL-2, IL-4, IL-10, INFγ) cytokines are evaluated. We also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional One-lung ventilation | Experimental | Other: Conventional One-Lung VentilationThe patients received a Tidal volume of 10 ml/kg (based on Predicted body weight) |
| Protective One-Lung Ventilation | Experimental | Other: Protective One-lung ventilationThe patients received a Tidal volume of 5 ml/kg (based on Predicted body weight) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective lobectomy and wedge resection
Key exclusion criteria (1 listed)
- emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional One-Lung VentilationVt 10 ml/kg | Other | Conventional One-lung ventilation |
| Protective One-lung ventilationVt 5 ml/kg | Other | Protective One-Lung Ventilation |
Primary outcome
local cytokine inflammatory response in the two study groups
Time frame: Change from Baseline cytokines level and the end of surgery (about 60 minutes)
The levels of cytokines were evaluated in broncho-alveolar lavage (BAL)
2 secondary outcomes
incidence of postoperative respiratory in the two study groups
Time frame: within 48 hours of the operation
lenght of stay in the two study groups
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Ventilator-Induced Lung Injury
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Not yet recruitingObservational study
Mechanical Power and Mortality in Mechanically Ventilated Adults
Mechanical Ventilation Complication, Ventilator Induced Lung Injury
Active, not recruiting
Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.
Ventilation, ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Trial of Total Lung Protective Ventilation in Adult VV-ECMO Patients With Severe ARDS
ARDS (Acute Respiratory Distress Syndrome), VV ECMO
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional One-Lung Ventilation and Protective One-lung ventilation in people with Ventilator-Induced Lung Injury and Inflammatory Response, run by University of Roma La Sapienza.
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 1 inclusion and 1 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
local cytokine inflammatory response in the two study groups (time frame: Change from Baseline cytokines level and the end of surgery (about 60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2017; AzTrials last refreshed its copy on 29 Oct 2026.