on Invasive Mechanical VentilationNCT04035915
Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure
A study testing Limited driving pressure and Conventional mechanical ventilation strategies in people with on Invasive Mechanical Ventilation and ARDS, run by Mahidol University at 1 site in Thailand.
Trial summary
Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- on Invasive Mechanical Ventilation, ARDS, Respiratory Failure
- What is being tested?
- Limited driving pressure and Conventional mechanical ventilation strategies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteThailand
- Study dates
- 25 Jul 2019to 31 Mar 2021
- 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
- Age ≥ 18 year old MICU patient
- On Invasive mechanical ventilator less than 24 hr. before randomization
Who cannot join
- Suspected death within 48 hr. after randomization
- patients with tracheostomy tube
- Pregnancy
- Do not attempt resuscitation order
- Patient with ECMO before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.
Read the detailed description
Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.
To compare lung injury score (LIS, Murray score) after invasive mechanical ventilation 7 days between groups of limited driving pressure ventilation versus low tidal volume ventilation strategies.
- Being tested
- Limited driving pressure, Conventional mechanical ventilation strategies
- Keywords
- Limited driving pressure, Low tidal volume, Lung injury score
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited driving pressureProcedure or surgery
Keep driving pressure <15 cmH2O
Conventional mechanical ventilation strategiesProcedure or surgery
Keep tidalvolume </= 8
| Study group | Role | What they receive |
|---|---|---|
| Limited driving pressure ventilation | Experimental | Not described Receives: Procedure: Limited driving pressure |
| Conventional mechanical ventilation strategies | Experimental | Not described Receives: Procedure: Conventional mechanical ventilation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung injury score
Lung injury score (LIS, Murray score)
Measured: Day 7 after invasive mechanical ventilation
Secondary outcomes (2)
28 days Mortality
28 days Mortality
Measured: Upto 28 days
New onset of ARDS
New onset of ARDS
Measured: Upto 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start25 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for on Invasive Mechanical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surat Tongyoo, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035915
- Sponsor's protocol ID
- SI828/2016
- Status last verified
- Sep 2021
- First submitted
- 25 Jul 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tongyoo S, Viarasilpa T, Deawtrakulchai P, Subpinyo S, Suppasilp C, Permpikul C. Comparison of limited driving pressure ventilation and low tidal volume strategies in adults with acute respiratory failure on mechanical ventilation: a randomized controlled trial. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241249152. doi: 10.1177/17534666241249152.
PubMed 38726850
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04035915
- Acronym / sponsor ID
- SI828/2016
- Keywords
- Limited driving pressure, Low tidal volume, Lung injury score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 Jul 2019 (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.
Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.
Detailed description
Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.
To compare lung injury score (LIS, Murray score) after invasive mechanical ventilation 7 days between groups of limited driving pressure ventilation versus low tidal volume ventilation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited driving pressure ventilation | Experimental | Procedure: Limited driving pressure |
| Conventional mechanical ventilation strategies | Experimental | Procedure: Conventional mechanical ventilation strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 year old MICU patient
- On Invasive mechanical ventilator less than 24 hr. before randomization
Key exclusion criteria (5 listed)
- Suspected death within 48 hr. after randomization
- patients with tracheostomy tube
- Pregnancy
- Do not attempt resuscitation order
- Patient with ECMO before randomization
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 |
|---|---|---|
| Limited driving pressureKeep driving pressure <15 cmH2O | Procedure or surgery | Limited driving pressure ventilation |
| Conventional mechanical ventilation strategiesKeep tidalvolume </= 8 | Procedure or surgery | Conventional mechanical ventilation strategies |
Primary outcome
Lung injury score
Time frame: Day 7 after invasive mechanical ventilation
Lung injury score (LIS, Murray score)
2 secondary outcomes
28 days Mortality
Time frame: Upto 28 days
New onset of ARDS
Time frame: Upto 28 days
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 24 Sep 2021.
- Derived from this study: PubMed 38726850Tongyoo S, Viarasilpa T, Deawtrakulchai P, Subpinyo S, Suppasilp C, Permpikul C. Comparison of limited driving pressure ventilation and low tidal volume strategies in adults with acute respiratory failure on mechanical ventilation: a randomized controlled trial. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241249152. doi: 10.1177/17534666241249152.
- Individual participant dataSharing planned: Yes
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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.
Surat Tongyoo, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited driving pressure and Conventional mechanical ventilation strategies in people with on Invasive Mechanical Ventilation and ARDS, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 5 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 24 Sep 2021. 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 Thailand. 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?
Lung injury score (time frame: Day 7 after invasive mechanical ventilation). 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 NCT04035915, which also lists 1 linked publication.
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 24 Sep 2021.