<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02184793</url>
  </required_header>
  <id_info>
    <org_study_id>P080407</org_study_id>
    <nct_id>NCT02184793</nct_id>
  </id_info>
  <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</brief_title>
  <acronym>Inclinometre2</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of&#xD;
      bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in&#xD;
      those patients. However, such a bed inclination frame is still difficult to maintain in&#xD;
      day-to-day care.&#xD;
&#xD;
      The aim of the study is to evaluate the impact of an electronic monitoring device on the&#xD;
      proportion of time spent per day in semi-recumbent position, as defined by a head of bed&#xD;
      inclination between 40° and 50°, in mechanically-ventilated patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and&#xD;
      50°) is an international guidance to prevent ventilator-associated pneumopathy which is the&#xD;
      main nosocomial infection in intensive care unit. However, maintaining such an inclination&#xD;
      has been shown to be difficult in day-to-day care.&#xD;
&#xD;
      This could be improved by using an assistance device that would measure inclination of the&#xD;
      head of bed in real time and trigger an alarm when the value order is not reached, hence&#xD;
      allowing a quick readjustment if necessary.&#xD;
&#xD;
      The investigators want to evaluate en electronic monitoring device (EMD) that is removable&#xD;
      and adjustable to all beds, which would allow a whole intensive care unit to be fully&#xD;
      equipped at low cost.&#xD;
&#xD;
      Hypothesis : using an EMD could improve the proportion of time spent per day in&#xD;
      semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in&#xD;
      mechanically-ventilated patients.&#xD;
&#xD;
      Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time&#xD;
      spent per day in semi-recumbent position, as defined by a head of bed inclination between 40°&#xD;
      and 50°, in mechanically-ventilated patients.&#xD;
&#xD;
      Secondary objectives :&#xD;
&#xD;
        -  to evaluate the impact of the EMD on the head of bed inclination overall mean&#xD;
&#xD;
        -  to evaluate the impact of the EMD on the proportion of time spent per day with a head of&#xD;
           bed inclination superior to 30°&#xD;
&#xD;
        -  to evaluate the impact of the EMD on the proportion of time spent per day with a head of&#xD;
           bed inclination between 30° and 45°&#xD;
&#xD;
        -  to study factors associated to a head of bed inclination inferior to 30° for more than&#xD;
           12hrs per 24hrs&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    not enough inclusion&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of time spent per day in semirecumbent position as defined by a head of bed inclination between 40° and 50°</measure>
    <time_frame>24hrs</time_frame>
    <description>head of bed inclination recording during 24h</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>head of bed inclination overall mean</measure>
    <time_frame>24hrs</time_frame>
    <description>head of bed inclination recording during 24h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of time spent per day with a head of bed inclination superior to 30°</measure>
    <time_frame>24hrs</time_frame>
    <description>head of bed inclination recording during 24h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of time spent per day with a head of bed inclination between 30° and 45°</measure>
    <time_frame>24hrs</time_frame>
    <description>head of bed inclination recording during 24h</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Mechanically-ventilated Patients</condition>
  <arm_group>
    <arm_group_label>EMD (Inclinomax) then usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h.&#xD;
Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care then EMD (Inclinomax)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h.&#xD;
EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EMD (Inclinomax)</intervention_name>
    <description>EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on</description>
    <arm_group_label>EMD (Inclinomax) then usual care</arm_group_label>
    <arm_group_label>usual care then EMD (Inclinomax)</arm_group_label>
    <other_name>EMD (electronic monitoring device)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with invasive mechanical ventilation&#xD;
&#xD;
          -  expected mechanical ventilation duration for more than 48h after inclusion&#xD;
&#xD;
          -  signature of an informed consent by a relative&#xD;
&#xD;
          -  patient affiliated to a social security scheme (beneficiary or assignee)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18 years old&#xD;
&#xD;
          -  mechanical ventilation with tracheotomy&#xD;
&#xD;
          -  contraindication to semirecumbent position (e.g., spinal cord injury, important sacral&#xD;
             bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation)&#xD;
             or expected indication to another position within the following 48 h after inclusion&#xD;
             (e.g., ventral decubitus for hypoxemia pulmonary pathology)&#xD;
&#xD;
          -  SAPS II score &gt; 65 at the admission (moribund patients)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lila Bouadma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Bichat Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>June 13, 2017</last_update_submitted>
  <last_update_submitted_qc>June 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mechanical ventilation</keyword>
  <keyword>semirecumbent position</keyword>
  <keyword>electronic monitoring device</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02184793
org study id: P080407
nct id: NCT02184793
lead sponsor: 
has dmc: No
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.
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
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
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
description: head of bed inclination recording during 24h
measure: head of bed inclination overall mean
time frame: 24hrs
description: head of bed inclination recording during 24h
measure: proportion of time spent per day with a head of bed inclination superior to 30°
time frame: 24hrs
description: head of bed inclination recording during 24h
measure: proportion of time spent per day with a head of bed inclination between 30° and 45°
time frame: 24hrs
description: head of bed inclination recording during 24h
arm group label: EMD (Inclinomax) then usual care
arm group type: Other
description: 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.
arm group label: usual care then EMD (Inclinomax)
arm group type: Other
description: 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.
intervention type: Device
intervention name: EMD (Inclinomax)
description: EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on
arm group label: EMD (Inclinomax) then usual care
arm group label: usual care then EMD (Inclinomax)
other name: EMD (electronic monitoring device)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lila Bouadma, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor