Acute Mechanical Ventilatory FailureSleepICUNCT02095496
Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders
A study testing Intellivent-ASV and Conventional ventilation in people with Acute Mechanical Ventilatory Failure and Psychosis Associated With Intensive Care, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known factor in this deterioration.The investigators hypothesize that close-loop ventilation mode (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the patient needs. Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Acute Mechanical Ventilatory Failure, Psychosis Associated With Intensive Care
- What is being tested?
- Intellivent-ASV and Conventional ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Dec 2015
- 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 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient under invasive mechanical ventilation since at least 6 hours and for expected at least 48 hours duration, including a continuous period of 24h, from 2 p.m. to 2 p.m. the next day.
- Age > 18 years
- Body Mass Index < 40
- informed consent signed by the family
Who cannot join
- patient requiring neuo-muscular blocking agent or deep sedation enough to abolish spontaneous ventilatory effort
- patient with encephalopathy regardless of origin
- Patient with Glasgow coma scale score < 8
- Patient abusing of drug or alcohol
- patient with a contraindication for placement of a nasogastric tube such that sufferers of esophageal or gastric ulcer, tumors, diverticulitis or bleeding varices or patients with sinusitis epistaxis or having recently been operated on the nose or pharynx
- Patient with bleeding disorders
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- Patient with unstable respiratory situation as defined by a arterial oxygen partial pressure and inspired oxygen fraction ratio (PaO2/FiO2) < 100 mmHg with positive end expiratory pressure (PEEP) > 12 cmH2O
- Patient with unstable hemodynamic situation as defined by Systolic Blood Pressure (SBP) < 75 mmHg despite a therapeutic optimization
- Inclusion in another research protocol submitted to consent
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Intensive Care Unit, Saint Luc university Hospital
Brussels, 1200
About this study
Official title: Contribution to the Understanding of the Involvement of Mechanical Ventilation in ICU Patients Sleep Disorders
Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known factor in this deterioration.The investigators hypothesize that close-loop ventilation mode (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the patient needs.
Read the detailed description
In intensive care, conventional mechanical ventilation (pressure support) generates apneas and asynchronies during sleep. Intellivent-ASV would be able to avoid apneas, providing controlled cycles when respiratory rate become too low. Moreover, the constant adjustment of ventilatory parameters to the patient needs would avoid asynchronies between the ventilator and the patient ventilatory drive.
- Being tested
- Intellivent-ASV, Conventional ventilation
- Keywords
- sleep, intensive care, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellivent-ASVDevice
Also called closed-loop ventilation
12 hours of mechanical ventilation with intellivent-ASV
Conventional ventilationDevice
Also called pressure support ventilation
12 hours of mechanical ventilation with pressure support ventilation
| Study group | Role | What they receive |
|---|---|---|
| Intellivent-ASV | Experimental | Patients will receive Intellivent-ASV ventilation during 12 hours Receives: Device: Intellivent-ASV |
| Conventional ventilation | Active comparator | Patients will receive pressure support ventilation during 12 hours Receives: Device: Conventional ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep fragmentation index
= number of awakenings and arousals per hour of sleep
Measured: 12 hours
Secondary outcomes (2)
duration of sleep episodes
Measured: 12 hours
Distribution of the sleep
distribution of the sleep during day and night
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mechanical Ventilatory FailureStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Bialais, PhD Student, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095496
- Sponsor's protocol ID
- StLuc
- Acronym
- SleepICU
- Status last verified
- Jan 2016
- First submitted
- 4 Mar 2014
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution to the Understanding of the Involvement of Mechanical Ventilation in ICU Patients Sleep Disorders
- ClinicalTrials.gov ID
- NCT02095496
- Acronym / sponsor ID
- SleepICU / StLuc
- Keywords
- sleep, intensive care, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Mar 2014 (estimated)
- 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.
Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known factor in this deterioration.The investigators hypothesize that close-loop ventilation mode (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the patient needs.
Detailed description
In intensive care, conventional mechanical ventilation (pressure support) generates apneas and asynchronies during sleep. Intellivent-ASV would be able to avoid apneas, providing controlled cycles when respiratory rate become too low. Moreover, the constant adjustment of ventilatory parameters to the patient needs would avoid asynchronies between the ventilator and the patient ventilatory drive.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intellivent-ASV | Experimental | Device: Intellivent-ASVPatients will receive Intellivent-ASV ventilation during 12 hours |
| Conventional ventilation | Active comparator | Device: Conventional ventilationPatients will receive pressure support ventilation during 12 hours |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient under invasive mechanical ventilation since at least 6 hours and for expected at least 48 hours duration, including a continuous period of 24h, from 2 p.m. to 2 p.m. the next day.
- Age > 18 years
- Body Mass Index < 40
- informed consent signed by the family
Key exclusion criteria (9 listed)
- patient requiring neuo-muscular blocking agent or deep sedation enough to abolish spontaneous ventilatory effort
- patient with encephalopathy regardless of origin
- Patient with Glasgow coma scale score < 8
- Patient abusing of drug or alcohol
- patient with a contraindication for placement of a nasogastric tube such that sufferers of esophageal or gastric ulcer, tumors, diverticulitis or bleeding varices or patients with sinusitis epistaxis or having recently been operated on the nose or pharynx
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 |
|---|---|---|
| Intellivent-ASVAlso: closed-loop ventilation12 hours of mechanical ventilation with intellivent-ASV | Device | Intellivent-ASV |
| Conventional ventilationAlso: pressure support ventilation12 hours of mechanical ventilation with pressure support ventilation | Device | Conventional ventilation |
Primary outcome
Sleep fragmentation index
Time frame: 12 hours
= number of awakenings and arousals per hour of sleep
2 secondary outcomes
duration of sleep episodes
Time frame: 12 hours
Distribution of the sleep
Time frame: 12 hours
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 1 Feb 2016.
- Individual participant dataSharing planned: No
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Recruiting
Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation
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Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient
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Active, not recruitingObservational study
Assessment of PaO2/FiO2 Ratio Pre and POst INTubation
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Recruiting
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
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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.
Emilie Bialais, PhD Student principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intellivent-ASV and Conventional ventilation in people with Acute Mechanical Ventilatory Failure and Psychosis Associated With Intensive Care, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 9 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 1 Feb 2016. 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 Belgium. 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?
Sleep fragmentation index (time frame: 12 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 1 Feb 2016.