Mechanically-ventilated PatientsInclinometre2NCT02184793
Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit
A study testing EMD (Inclinomax) in people with Mechanically-ventilated Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically-ventilated Patients
- What is being tested?
- EMD (Inclinomax)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with invasive mechanical ventilation
- expected mechanical ventilation duration for more than 48h after inclusion
- signature of an informed consent by a relative
- patient affiliated to a social security scheme (beneficiary or assignee)
Who cannot join
- age<18 years old
- mechanical ventilation with tracheotomy
- contraindication to semirecumbent position (e.g., spinal cord injury, important sacral bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation) or expected indication to another position within the following 48 h after inclusion (e.g., ventral decubitus for hypoxemia pulmonary pathology)
- SAPS II score > 65 at the admission (moribund patients)
Trial locations and contacts
1 site in 1 country.
About this study
Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.
The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
Read the detailed description
Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and 50°) is an international guidance to prevent ventilator-associated pneumopathy which is the main nosocomial infection in intensive care unit. However, maintaining such an inclination has been shown to be difficult in day-to-day care.
This could be improved by using an assistance device that would measure inclination of the head of bed in real time and trigger an alarm when the value order is not reached, hence allowing a quick readjustment if necessary.
The investigators want to evaluate en electronic monitoring device (EMD) that is removable and adjustable to all beds, which would allow a whole intensive care unit to be fully equipped at low cost.
Hypothesis : using an EMD could improve the proportion of time spent per day in semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in mechanically-ventilated patients.
Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
Secondary objectives :
- to evaluate the impact of the EMD on the head of bed inclination overall mean
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination superior to 30°
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination between 30° and 45°
- to study factors associated to a head of bed inclination inferior to 30° for more than 12hrs per 24hrs
- Conditions
- Mechanically-ventilated Patients
- Being tested
- EMD (Inclinomax)
- Keywords
- mechanical ventilation, semirecumbent position, electronic monitoring device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMD (Inclinomax)Device
Also called EMD (electronic monitoring device)
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on
| Study group | Role | What they receive |
|---|---|---|
| EMD (Inclinomax) then usual care | Other | EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h.
Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h. Receives: Device: EMD (Inclinomax) |
| usual care then EMD (Inclinomax) | Other | Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h.
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h. Receives: Device: EMD (Inclinomax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50°
head of bed inclination recording during 24h
Measured: 24hrs
Secondary outcomes (3)
head of bed inclination overall mean
head of bed inclination recording during 24h
Measured: 24hrs
proportion of time spent per day with a head of bed inclination superior to 30°
head of bed inclination recording during 24h
Measured: 24hrs
proportion of time spent per day with a head of bed inclination between 30° and 45°
head of bed inclination recording during 24h
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: not enough inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically-ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lila Bouadma, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184793
- Sponsor's protocol ID
- P080407
- Acronym
- Inclinometre2
- Status last verified
- May 2017
- First submitted
- 25 Jun 2014
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02184793
- Acronym / sponsor ID
- Inclinometre2 / P080407
- Conditions
- Mechanically-ventilated Patients
- Keywords
- mechanical ventilation, semirecumbent position, electronic monitoring device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough inclusion
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Jul 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.
Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.
The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
Detailed description
Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and 50°) is an international guidance to prevent ventilator-associated pneumopathy which is the main nosocomial infection in intensive care unit. However, maintaining such an inclination has been shown to be difficult in day-to-day care.
This could be improved by using an assistance device that would measure inclination of the head of bed in real time and trigger an alarm when the value order is not reached, hence allowing a quick readjustment if necessary.
The investigators want to evaluate en electronic monitoring device (EMD) that is removable and adjustable to all beds, which would allow a whole intensive care unit to be fully equipped at low cost.
Hypothesis : using an EMD could improve the proportion of time spent per day in semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in mechanically-ventilated patients.
Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.
Secondary objectives :
- to evaluate the impact of the EMD on the head of bed inclination overall mean
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination superior to 30°
- to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination between 30° and 45°
- to study factors associated to a head of bed inclination inferior to 30° for more than 12hrs per 24hrs
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMD (Inclinomax) then usual care | Other | Device: EMD (Inclinomax)EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h. Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h. |
| usual care then EMD (Inclinomax) | Other | Device: EMD (Inclinomax)Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h. EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with invasive mechanical ventilation
- expected mechanical ventilation duration for more than 48h after inclusion
- signature of an informed consent by a relative
- patient affiliated to a social security scheme (beneficiary or assignee)
Key exclusion criteria (4 listed)
- age<18 years old
- mechanical ventilation with tracheotomy
- contraindication to semirecumbent position (e.g., spinal cord injury, important sacral bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation) or expected indication to another position within the following 48 h after inclusion (e.g., ventral decubitus for hypoxemia pulmonary pathology)
- SAPS II score > 65 at the admission (moribund patients)
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 |
|---|---|---|
| EMD (Inclinomax)Also: EMD (electronic monitoring device)EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on | Device | EMD (Inclinomax) then usual care, usual care then EMD (Inclinomax) |
Primary outcome
proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50°
Time frame: 24hrs
head of bed inclination recording during 24h
3 secondary outcomes
head of bed inclination overall mean
Time frame: 24hrs
proportion of time spent per day with a head of bed inclination superior to 30°
Time frame: 24hrs
proportion of time spent per day with a head of bed inclination between 30° and 45°
Time frame: 24hrs
Results and safety
The study was stopped early (reason given: not enough inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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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.
Lila Bouadma, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMD (Inclinomax) in people with Mechanically-ventilated Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 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: stopped early, as of the sponsor's last update on 15 Jun 2017. 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 France. 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 was stopped early (reason given: not enough inclusion). Results are not available in the source record.
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?
proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50° (time frame: 24hrs). 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 15 Jun 2017.