Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit (Inclinometre2)

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.

Study Overview

• Status: Terminated
• Conditions: Mechanically-ventilated Patients
• Intervention / Treatment: Device: EMD (Inclinomax)

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EMD (Inclinomax) then usual care; 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.	Device: EMD (Inclinomax); EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on; Other Names: EMD (electronic monitoring device)
Other: usual care then 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.	Device: EMD (Inclinomax); EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on; Other Names: EMD (electronic monitoring device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
head of bed inclination overall mean	head of bed inclination recording during 24h	24hrs
proportion of time spent per day with a head of bed inclination superior to 30°	head of bed inclination recording during 24h	24hrs
proportion of time spent per day with a head of bed inclination between 30° and 45°	head of bed inclination recording during 24h	24hrs

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Lila BOUADMA, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: mechanical ventilation; semirecumbent position; electronic monitoring device
• Other Study ID Numbers: P080407