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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75018
        • Hopital Bichat Claude Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.

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.

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°
Time Frame: 24hrs
head of bed inclination recording during 24h
24hrs

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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