Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit

Mechanically-ventilated Patients Clinical Trial

— Inclinometre2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02184793
• Other study ID #: P080407
• Status: Terminated
• Phase: N/A
• First received: June 25, 2014
• Last updated: June 13, 2017
• Start date: June 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Mechanically-ventilated Patients

Intervention

Device:
• EMD (Inclinomax)
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on

Locations

Country	Name	City	State
France	Hôpital Bichat Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24hrs
Secondary	head of bed inclination overall mean	head of bed inclination recording during 24h	24hrs
Secondary	proportion of time spent per day with a head of bed inclination superior to 30°	head of bed inclination recording during 24h	24hrs
Secondary	proportion of time spent per day with a head of bed inclination between 30° and 45°	head of bed inclination recording during 24h	24hrs