<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/NCT04446559</url>
  </required_header>
  <id_info>
    <org_study_id>CHRO-2020-03</org_study_id>
    <nct_id>NCT04446559</nct_id>
  </id_info>
  <brief_title>Sitting Position and Blood Oxygenation in ICU Patient</brief_title>
  <acronym>FALCON</acronym>
  <official_title>Effect of &quot; Sitting in a Chair &quot; Versus &quot; Conventional Semi-recumbent In-bed Position &quot; on the Oxygenation Level for ICU Non-sedated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional d'Orléans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional d'Orléans</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The positioning of the ICU patient is a daily concern of the medical and paramedical teams.&#xD;
      Developments in emergency medicine and sedation and analgesia techniques have made it&#xD;
      possible to reduce patient mortality. However, considered too unstable, patients were no&#xD;
      longer mobilized outside the bed until the complete resolution of the symptoms that led to&#xD;
      hospitalization or surgery.&#xD;
&#xD;
      Despite encouraging results for early mobilization, bed and rest remained the most widespread&#xD;
      positioning technique worldwide with the emergence of intensive care units, mechanical&#xD;
      ventilation and sedation/analgesia/curarization. The result is peripheral muscular amyotrophy&#xD;
      and respiratory muscular amyotrophy, with increased length of stay and exacerbated&#xD;
      morbidity/mortality several years after discharge from ICU.&#xD;
&#xD;
      Numerous studies have shown the value of early mobilization of the ICU patient to preserve&#xD;
      functional and muscular capital.&#xD;
&#xD;
      However, few studies have evaluated the value of mobilizing the ICU patient from the bed in&#xD;
      order to improve oxygenation. The lack of mobility outside the bed causes condensation of the&#xD;
      pulmonary parenchyma at the bases and in the dorsal region when the patient is lying down or&#xD;
      in a prolonged semi-seated position.&#xD;
&#xD;
      In awake spontaneously ventilated patients, whether intubated on ventilatory support&#xD;
      (Pressure Support), non-invasive ventilation (NIV) or high flow nasal oxygen therapy (HFNO),&#xD;
      the reference position is a semi-seated patient with the head of the resuscitation bed tilted&#xD;
      at 30°. The problem with this position in the bed is that patients tend to slide toward the&#xD;
      foot of the bed. This migration is due to gravity or the design of the ICU bed. The end&#xD;
      result of this migration is that the inclination indicated by the bed head inclinometer does&#xD;
      not correspond to the actual angulation between the patient's lower limbs and trunk. The&#xD;
      patient finds himself &quot;compressed&quot; in the lower abdomen, which can lead to compression of the&#xD;
      diaphragm and thus hypoventilation in the postero-caudal regions of the lungs.&#xD;
&#xD;
      Our hypothesis is that the chair position (outside the ICU bed) allows, without modification&#xD;
      of the ventilatory parameters, to improve the alveolar ventilation and thus the oxygenation&#xD;
      of the arterial blood, compared to the &quot;natural&quot; semi-seated position in the ICU bed, in&#xD;
      patients with spontaneous ventilation (PS/NIV/HFNO).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a monocentric, comparative, randomized, open-label trial comparing two methods of&#xD;
      &quot;seated&quot; positioning of the ICU patient, chair versus natural position in bed, on arterial&#xD;
      blood oxygenation&#xD;
&#xD;
        1. Sitting in a Chair position For patients randomized in the chair group, we will perform&#xD;
           the transfer to the chair immediately after the morning arterial blood gas. The chair&#xD;
           position will be maintained for 3 hours, if the patient shows no clinical signs of&#xD;
           discomfort or intolerance.&#xD;
&#xD;
        2. Semi-recumbent position in bed The patient will benefit from conventional positioning&#xD;
           techniques in the ICU bed. With the help of the medical monitoring software present in&#xD;
           the wards, we will note the different nursing care given to the patient during the 3&#xD;
           hours following the morning arterial gasometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Once the patient is included and the randomization is made, the positioning method will be applied for only one period of 3 hours (if optimal tolerance) and arterial gasometry in relation to the main objective will only be performed on this occasion. For the rest of the stay, the patient will benefit from the usual examinations and positioning techniques in the corresponding ICU.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the PaO2/FiO2 ratio between arterial gasometry at the end of the night and arterial gasometry at the end of the positioning sequence.</measure>
    <time_frame>Hour 3</time_frame>
    <description>Comparison of the PaO2/FiO2 ratio between early seating out of the bed for ICU patient under spontaneous breathing (NIV/PS/HFNO) and patients in the natural in bed position.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of intolerance criteria regarding the randomization group.</measure>
    <time_frame>Hour 3</time_frame>
    <description>The objective is to compare between the two groups the clinical tolerance during positioning</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">258</enrollment>
  <condition>ICU Patient</condition>
  <arm_group>
    <arm_group_label>Sitting in a chair position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Semi-recumbent in bed position</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patient will benefit from conventional positioning techniques in the ICU bed. With the help of the medical monitoring software present in the wards, we will note the different nursing care given to the patient during the 3 hours following the morning arterial gasometry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sitting in chair position</intervention_name>
    <description>For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.</description>
    <arm_group_label>Sitting in a chair position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥ 18 years old in intensive care unit (ICU) or surgical intensive care unit&#xD;
             (SICU)&#xD;
&#xD;
          -  Intubated and under mechanical invasive ventilation for at least 24 hours or under&#xD;
             non-invasive ventilation for more than 12 hours a day or under continuous high-flow&#xD;
             nasal oxygen therapy for more than 24 hours or alternating NIV/HFNO.&#xD;
&#xD;
          -  Patient or next of kin who has expressed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tracheotomized patient&#xD;
&#xD;
          -  Patient with a contraindication to sitting in a chair&#xD;
&#xD;
               -  Deep vein thrombosis not effectively anticoagulated&#xD;
&#xD;
               -  Fracture or orthopaedic disorder contra indicating mobilization&#xD;
&#xD;
               -  Lung Embolism&#xD;
&#xD;
               -  Hemodynamic instability with Average Arterial Pressure &lt; 65 mmHg or a vasopressor&#xD;
                  amine dose greater than 0.5 ug/kg/min&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Therapeutic limitation with decision of non-reintubation in case of extubation failure&#xD;
&#xD;
          -  Non-affiliated or non-beneficiary patient of a social security scheme&#xD;
&#xD;
          -  Person deprived of liberty by judicial or administrative decision&#xD;
&#xD;
          -  Person under guardianship or curators&#xD;
&#xD;
          -  Patient already included in the study&#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>Guillaume FOSSAT</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Orléans</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurélie DESPUJOLS</last_name>
    <phone>+33238744071</phone>
    <email>aurelie.despujols@chr-orleans.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elodie POUGOUE TOUKO</last_name>
    <phone>+33238744086</phone>
    <email>elodie.pougoue-touko@chr-orleans.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHR d'Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guillaume FOSSAT</last_name>
      <email>guillaume.fossat@chr-orleans.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Domanski Z, Niezabitowski K, Latawiec-Mazurkiewicz I. [Phlebography of the spermatic vein near the unpalpable testicle]. Rofo. 1980 Sep;133(3):322-4. No abstract available. German.</citation>
    <PMID>6110624</PMID>
  </reference>
  <reference>
    <citation>Castellani G, Vincenzi G, Brugnolo E. [Reliability of parapulp support in the coronal reconstruction of silver amalgam in posterior teeth]. Dent Cadmos. 1983 Jun;51(6):25-32. No abstract available. Italian.</citation>
    <PMID>6583091</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bed Rest</keyword>
  <keyword>Sitting Position</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Semi-recumbent Position</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/NCT04446559
org study id: CHRO-2020-03
nct id: NCT04446559
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The positioning of the ICU patient is a daily concern of the medical and paramedical teams.
      Developments in emergency medicine and sedation and analgesia techniques have made it
      possible to reduce patient mortality. However, considered too unstable, patients were no
      longer mobilized outside the bed until the complete resolution of the symptoms that led to
      hospitalization or surgery.

      Despite encouraging results for early mobilization, bed and rest remained the most widespread
      positioning technique worldwide with the emergence of intensive care units, mechanical
      ventilation and sedation/analgesia/curarization. The result is peripheral muscular amyotrophy
      and respiratory muscular amyotrophy, with increased length of stay and exacerbated
      morbidity/mortality several years after discharge from ICU.

      Numerous studies have shown the value of early mobilization of the ICU patient to preserve
      functional and muscular capital.

      However, few studies have evaluated the value of mobilizing the ICU patient from the bed in
      order to improve oxygenation. The lack of mobility outside the bed causes condensation of the
      pulmonary parenchyma at the bases and in the dorsal region when the patient is lying down or
      in a prolonged semi-seated position.

      In awake spontaneously ventilated patients, whether intubated on ventilatory support
      (Pressure Support), non-invasive ventilation (NIV) or high flow nasal oxygen therapy (HFNO),
      the reference position is a semi-seated patient with the head of the resuscitation bed tilted
      at 30°. The problem with this position in the bed is that patients tend to slide toward the
      foot of the bed. This migration is due to gravity or the design of the ICU bed. The end
      result of this migration is that the inclination indicated by the bed head inclinometer does
      not correspond to the actual angulation between the patient's lower limbs and trunk. The
      patient finds himself "compressed" in the lower abdomen, which can lead to compression of the
      diaphragm and thus hypoventilation in the postero-caudal regions of the lungs.

      Our hypothesis is that the chair position (outside the ICU bed) allows, without modification
      of the ventilatory parameters, to improve the alveolar ventilation and thus the oxygenation
      of the arterial blood, compared to the "natural" semi-seated position in the ICU bed, in
      patients with spontaneous ventilation (PS/NIV/HFNO).
This is a monocentric, comparative, randomized, open-label trial comparing two methods of
      "seated" positioning of the ICU patient, chair versus natural position in bed, on arterial
      blood oxygenation

        1. Sitting in a Chair position For patients randomized in the chair group, we will perform
           the transfer to the chair immediately after the morning arterial blood gas. The chair
           position will be maintained for 3 hours, if the patient shows no clinical signs of
           discomfort or intolerance.

        2. Semi-recumbent position in bed The patient will benefit from conventional positioning
           techniques in the ICU bed. With the help of the medical monitoring software present in
           the wards, we will note the different nursing care given to the patient during the 3
           hours following the morning arterial gasometry.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Once the patient is included and the randomization is made, the positioning method will be applied for only one period of 3 hours (if optimal tolerance) and arterial gasometry in relation to the main objective will only be performed on this occasion. For the rest of the stay, the patient will benefit from the usual examinations and positioning techniques in the corresponding ICU.
primary purpose: Other
masking: None (Open Label)
measure: Evolution of the PaO2/FiO2 ratio between arterial gasometry at the end of the night and arterial gasometry at the end of the positioning sequence.
time frame: Hour 3
description: Comparison of the PaO2/FiO2 ratio between early seating out of the bed for ICU patient under spontaneous breathing (NIV/PS/HFNO) and patients in the natural in bed position.
measure: Incidence of intolerance criteria regarding the randomization group.
time frame: Hour 3
description: The objective is to compare between the two groups the clinical tolerance during positioning
arm group label: Sitting in a chair position
arm group type: Experimental
description: For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.
arm group label: Semi-recumbent in bed position
arm group type: No Intervention
description: The patient will benefit from conventional positioning techniques in the ICU bed. With the help of the medical monitoring software present in the wards, we will note the different nursing care given to the patient during the 3 hours following the morning arterial gasometry.
intervention type: Procedure
intervention name: Sitting in chair position
description: For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.
arm group label: Sitting in a chair position
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume FOSSAT
role: Principal Investigator
affiliation: CHR Orléans
last name: Aurélie DESPUJOLS
phone: +33238744071
email: aurelie.despujols@chr-orleans.fr
last name: Elodie POUGOUE TOUKO
phone: +33238744086
email: elodie.pougoue-touko@chr-orleans.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Domanski Z, Niezabitowski K, Latawiec-Mazurkiewicz I. [Phlebography of the spermatic vein near the unpalpable testicle]. Rofo. 1980 Sep;133(3):322-4. No abstract available. German.
PMID: 6110624
citation: Castellani G, Vincenzi G, Brugnolo E. [Reliability of parapulp support in the coronal reconstruction of silver amalgam in posterior teeth]. Dent Cadmos. 1983 Jun;51(6):25-32. No abstract available. Italian.
PMID: 6583091
responsible party type: Sponsor