ARDS, HumanLIPSNCT03783468
LIght Sedation Pressure Support
A study testing decrease of sedation doses and switch of ventilator settings in people with ARDS, Human, run by University Hospital, Lille.
Trial summary
Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular. Light sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- What is being tested?
- decrease of sedation doses and switch of ventilator settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2023
- 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
- ARDS (Berlin definition)
- social insurance
Who cannot join
- neuromuscular disorders
- pregnancy
- need for muscular paralysis
- need for deep neurosedation
- more than 24hrs of artificial ventilation
- cystic fibrosis
About this study
Official title: Early LIght Sedation Pressure Support in ARDS Patients
Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.
Light sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure.
The goal of the study is to measure transpulmonary pressure before sedation decrease and after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.
- Conditions
- ARDS, Human
- Being tested
- decrease of sedation doses and switch of ventilator settings
- 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.
decrease of sedation doses and switch of ventilator settingsOther
tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation
| Study group | Role | What they receive |
|---|---|---|
| light sedation pressure support ventilation | Experimental | Not described Receives: Other: decrease of sedation doses and switch of ventilator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
transpulmonary pressure at early stabilization of patient
transpulmonary pressure (Paw - Peso < 24 cmH2O)
Measured: when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours
Secondary outcomes (11)
oxygenation modification
PaO2/FiO2
Measured: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
arterial pressure modification
Mean arterial pressure
Measured: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
Heart rate modification
heart rate
Measured: stabilization of ventilator settings;1hour after stabilization of ventilator settings
vasopressor dose modification
vasopressor dose in norepinephrine equivalent
Measured: stabilization of ventilator settings ; 1hour after stabilization of ventilator settings
acquired neuromyopathy
MRC <48/60
Measured: ICU discharge, an average 16 days
muscular volume decrease
quadriceps volume assessed by echography
Measured: at 24 hours; at day of extubation; ICU discharge, an average 16 days
ventilator free days
ventilator free days until day 28
Measured: during the first 28 days
delirium in ICU
CAM-ICU is a valid and reliable delirium assessment tool recommended by the Society of Critical Care Medicine (SCCM) in its 2013 Pain, Agitation and Delirium (PAD) guidelines. the presence of delirium is confirmed in the presence of criteria 1, 2 and 3 or 4.
Measured: ICU discharge, an average 16 days
change of the functional respiratory parameters from baseline at 6 months
vital capacity, total pulmonary capacity,
Measured: at 6 months
PTSD
post traumatic stress disorder impact of event scale > 33 tems are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") and the total score (ranging from 0 to 88)
Measured: at 6 months
number of auto extubation
Measured: whatever until ICU discharge, an average 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey Ledoux, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783468
- Sponsor's protocol ID
- 2017_18
- Other IDs
- 2018-A01036-49
- Acronym
- LIPS
- Status last verified
- Mar 2022
- First submitted
- 11 Dec 2018
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early LIght Sedation Pressure Support in ARDS Patients
- ClinicalTrials.gov ID
- NCT03783468
- Acronym / sponsor ID
- LIPS / 2017_18
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Dec 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.
Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.
Light sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure.
The goal of the study is to measure transpulmonary pressure before sedation decrease and after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| light sedation pressure support ventilation | Experimental | Other: decrease of sedation doses and switch of ventilator settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ARDS (Berlin definition)
- social insurance
Key exclusion criteria (6 listed)
- neuromuscular disorders
- pregnancy
- need for muscular paralysis
- need for deep neurosedation
- more than 24hrs of artificial ventilation
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 |
|---|---|---|
| decrease of sedation doses and switch of ventilator settingstapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation | Other | light sedation pressure support ventilation |
Primary outcome
transpulmonary pressure at early stabilization of patient
Time frame: when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours
transpulmonary pressure (Paw - Peso < 24 cmH2O)
11 secondary outcomes
oxygenation modification
Time frame: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
arterial pressure modification
Time frame: stabilization of ventilator settings; 1hour after stabilization of ventilator settings
Heart rate modification
Time frame: stabilization of ventilator settings;1hour after stabilization of ventilator settings
vasopressor dose modification
Time frame: stabilization of ventilator settings ; 1hour after stabilization of ventilator settings
acquired neuromyopathy
Time frame: ICU discharge, an average 16 days
muscular volume decrease
Time frame: at 24 hours; at day of extubation; ICU discharge, an average 16 days
ventilator free days
Time frame: during the first 28 days
delirium in ICU
Time frame: ICU discharge, an average 16 days
change of the functional respiratory parameters from baseline at 6 months
Time frame: at 6 months
PTSD
Time frame: at 6 months
number of auto extubation
Time frame: whatever until ICU discharge, an average 16 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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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.
Geoffrey Ledoux, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
A study testing decrease of sedation doses and switch of ventilator settings in people with ARDS, Human, run by University Hospital, Lille.
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 6 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: withdrawn, as of the sponsor's last update on 17 Mar 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
transpulmonary pressure at early stabilization of patient (time frame: when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours). 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 Mar 2022.