Low Tidal Volume VentilationNCT03467607
A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation
A study testing tidal volume ventilation in people with Low Tidal Volume Ventilation, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
A study of two ventilatory strategies for low tidal volume ventilation compared to a control group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Tidal Volume Ventilation
- What is being tested?
- tidal volume ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIreland
- Study dates
- 20 Oct 2016to 30 Jun 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III lung resection surgery requiring one lung ventilation
Who cannot join
- ASA IV or above under 18 or over 80 years of age pregnancy previous lung lobectomy or pneumonectomy requirement for massive transfusion during the case BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
A study of two ventilatory strategies for low tidal volume ventilation compared to a control group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung ventilation.
Read the detailed description
This study investigated the feasibility of low tidal volume ventilation for one lung ventilation.
45 patients were recruited - 15 patients in each of three groups, 3ml/kg, 4ml/kg or usual care.
Outcomes studied were length of stay, 30 day mortality, unplanned ICU admission, evidence of respiratory failure or requirement for non-invasive ventilation, chest x-ray infiltrates and requirement for antibiotics.
- Conditions
- Low Tidal Volume Ventilation
- Being tested
- tidal volume ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tidal volume ventilationProcedure or surgery
low tidal volume ventilation
| Study group | Role | What they receive |
|---|---|---|
| 3ml/kg | Active comparator | 15 patients ventilated with 3ml/kg ideal body weight while on one lung ventilation Receives: Procedure: tidal volume ventilation |
| 4ml/kg | Active comparator | 15 patients ventilated with 4ml/kg ideal body weight while on one lung ventilation Receives: Procedure: tidal volume ventilation |
| control | Active comparator | 15 patients ventilated using the anaesthetists usual ventilation strategy Receives: Procedure: tidal volume ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evidence of injury to the ventilated lung
evidence of infiltrates in the non operative lung
Measured: post operatively up to 6 weeks post operatively
unplanned ICU admission
unplanned admission to the icu with respiratory issues
Measured: up to 6 weeks post operatively
Requirement for non-invasive ventilation
whether a patient in the trial requires niv for respiratory failure
Measured: up to 6 weeks post operatively
Hospital acquired pneumonia
pneumonia acquired in hospital
Measured: up to discharge at 6 weeks post operatively
Secondary outcomes (3)
length of hospital stay
number of days in hospital
Measured: until patient discharge at 6 weeks post operatively
length of icu stay
number of days in ICU
Measured: until patient discharge at 6 weeks post operatively
30 day mortality
number of patients who died within 30 days of their procedure
Measured: 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start20 Oct 2016
- Primary completion10 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Tidal Volume VentilationStudies 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
- Model description
- parallel assignment
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ignacio martin loeches, University of Dublin, Trinity College
- Investigators
- Ignacio Martin-Loeches, md, Study chair, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467607
- Sponsor's protocol ID
- 2016-11 List 43 (1)
- Status last verified
- Mar 2018
- First submitted
- 19 Jan 2018
- Last updated
- 16 Mar 2018
- 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 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation
- ClinicalTrials.gov ID
- NCT03467607
- Acronym / sponsor ID
- 2016-11 List 43 (1)
- Conditions
- Low Tidal Volume Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 16 Mar 2018 (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.
A study of two ventilatory strategies for low tidal volume ventilation compared to a control group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung ventilation.
Detailed description
This study investigated the feasibility of low tidal volume ventilation for one lung ventilation.
45 patients were recruited - 15 patients in each of three groups, 3ml/kg, 4ml/kg or usual care.
Outcomes studied were length of stay, 30 day mortality, unplanned ICU admission, evidence of respiratory failure or requirement for non-invasive ventilation, chest x-ray infiltrates and requirement for antibiotics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| 3ml/kg | Active comparator | Procedure: tidal volume ventilation15 patients ventilated with 3ml/kg ideal body weight while on one lung ventilation |
| 4ml/kg | Active comparator | Procedure: tidal volume ventilation15 patients ventilated with 4ml/kg ideal body weight while on one lung ventilation |
| control | Active comparator | Procedure: tidal volume ventilation15 patients ventilated using the anaesthetists usual ventilation strategy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III lung resection surgery requiring one lung ventilation
Key exclusion criteria (1 listed)
- ASA IV or above under 18 or over 80 years of age pregnancy previous lung lobectomy or pneumonectomy requirement for massive transfusion during the case BMI > 35
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 |
|---|---|---|
| tidal volume ventilationlow tidal volume ventilation | Procedure or surgery | 3ml/kg, 4ml/kg, control |
Primary outcome
Radiological evidence of injury to the ventilated lung
Time frame: post operatively up to 6 weeks post operatively
evidence of infiltrates in the non operative lung
unplanned ICU admission
Time frame: up to 6 weeks post operatively
unplanned admission to the icu with respiratory issues
Requirement for non-invasive ventilation
Time frame: up to 6 weeks post operatively
whether a patient in the trial requires niv for respiratory failure
Hospital acquired pneumonia
Time frame: up to discharge at 6 weeks post operatively
pneumonia acquired in hospital
3 secondary outcomes
length of hospital stay
Time frame: until patient discharge at 6 weeks post operatively
length of icu stay
Time frame: until patient discharge at 6 weeks post operatively
30 day mortality
Time frame: 30 days post operatively
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 16 Mar 2018.
- Individual participant dataSharing planned: No
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Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Coronary Artery Disease, Aortic Valve Disease
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Effects of Low Tidal Volume and Airway Pressure Release Ventilation on Lung Tissue Mechanics in ARDS Patients Under Mechanical Ventilation: A Prospective Randomized Crossover Study
ARDS (Acute Respiratory Distress Syndrome)
Not yet recruiting
Effects of End-inspiratory Pause on Ventilation
Acute Respiratory Distress Syndrome
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.
Ignacio Martin-Loeches, md study chair
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tidal volume ventilation in people with Low Tidal Volume Ventilation, run by University of Dublin, Trinity College at 1 site in Ireland.
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 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
Radiological evidence of injury to the ventilated lung (time frame: post operatively up to 6 weeks post operatively). The study lists 4 primary outcomes in all. 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 16 Mar 2018.