Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-02 @ 5:49 PM
Study NCT ID:
NCT02184793
Status:
TERMINATED
Last Update Posted:
2017-06-15
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Inclinometre2
Brief 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.
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: