<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/NCT03262493</url>
  </required_header>
  <id_info>
    <org_study_id>170217</org_study_id>
    <nct_id>NCT03262493</nct_id>
  </id_info>
  <brief_title>Feeding Tube Attachment Device Versus Conventional Fixation and Its Impact on Accidental Exit of Enteral Feeding Tubes</brief_title>
  <official_title>Use of Feeding Tube Attachment Device Versus Conventional Fixation and Its Impact on Accidental Exit of Enteral Feeding Tubes: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enteral nutritional therapy, fed through the gastrointestinal tract via a catheter, tube,&#xD;
      catheter, or stoma, delivers the nutrients distally to the oral cavity and may reduce&#xD;
      intrahospital malnutrition. Enteral probes are inserted, at the bedside, through the nose or&#xD;
      mouth into the stomach or duodenum. Among the main complications of the use enteral probes,&#xD;
      we can mention: displacement of the probe and administration of diet in the respiratory tract&#xD;
      or microaspirations. To prevent displacement, enteral probes are attached to the skin on the&#xD;
      nose or forehead by the use of micropore-type adhesive. In the probe the adhesive tape is put&#xD;
      in the form of &quot;tie&quot; and again fixed to the nose of the patient. The enteral probes&#xD;
      displacement rates with this technique are around 62%; in addition, the adhesive tape can&#xD;
      cause discomfort, nasal necrosis, skin lesions and skin sensitivity reactions to the patient.&#xD;
      More recently the nasal bridle, an anchor of the enteral feeding tube located around the&#xD;
      nasal septum or nasal septum, has been described as more effective in securing enteral probes&#xD;
      position over traditional tape attachment, but is not available in our environment. In&#xD;
      Brazil, the feeding tube attachment device (FTAD) is available. Until now, the performance of&#xD;
      FTAD in relation to enteral probe safety and accidental exit rates has not been described in&#xD;
      the literature. Material's FTAD is composed of a layer of hydrocolloid that is adhered to the&#xD;
      skin on the back of the nose and a polyurethane clamp that secures the enteral probe. Thus,&#xD;
      there was a need to evaluate the actual success in using the traditional mode of probe&#xD;
      attachment. It should be noted that very little scientific evidence is available in the&#xD;
      literature on such care, and this is due to the lack of well-designed studies on the subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomly assigned to the intervention group consisting of the use of the&#xD;
      feeding tube attachment device (FTAD) or the control group that will use the conventional&#xD;
      method of attachment with micropore adhesive tape and tape . The data will be compared by&#xD;
      Student's t test or Mann-Whitney and Pearson's chi-square, according to their distribution.&#xD;
      The project was approved by the Ethics and Research Committee of the Hospital de Clínicas de&#xD;
      Porto Alegre. Daily will be accessed through the diet map, available in the hospital&#xD;
      application, patients who are in use enteral nutrition. These data will be tabulated in the&#xD;
      screening worksheet, those who meet the eligibility criteria will be invited to participate&#xD;
      in the study and requested the reading and signing of the informed consent by the patient or&#xD;
      guardian. The study investigator will inform the allocation group to the guest patient.By&#xD;
      means of a structured questionnaire, socio demographic and clinical information will be&#xD;
      collected: age, gender, reason for current hospitalization, comorbidities and information&#xD;
      related to enteral probe (type of probe, place and date of insertion, number of medications&#xD;
      in use via enteral probe, type and the date of the last fixation change).&#xD;
&#xD;
      Traditional fixation with micropore and plaster is routinely performed by the nursing staff&#xD;
      every 24 hours or whenever necessary. The procedure will be performed as described in the&#xD;
      study protocol (item 1.1).&#xD;
&#xD;
      The feeding tube attachment device (FTAD) contains a layer of hydrocolloid that will attach&#xD;
      to the skin and a clamping clamp around the probe. The placement of the catheter fixation&#xD;
      device will be performed by the research nurses, these will be previously trained by the&#xD;
      manufacturer of the material. The fixing procedure is described in item 1.2.&#xD;
&#xD;
      Patients included will be evaluated daily for study outcomes up to the suspension of enteral&#xD;
      nutrition prescription, hospital discharge, death or up to 35 days of follow-up. Patients&#xD;
      starting enteral probe use on Saturday and Sunday can be up to 48 hours with the traditional&#xD;
      method of fixation and later will be randomized to the intervention or control group.&#xD;
&#xD;
      1.1 Control Group After inclusion in the study, initial evaluation and information to the&#xD;
      patient, the attending nurse will follow up on the exchange of the traditional enteral probe&#xD;
      fixation device that occurs according to the standard operating protocol in the institution&#xD;
      that recommends micropore fixation according to the &quot;tie&quot; technique and exchange Every 24&#xD;
      hours and whenever it is loose or with presence of dirt.&#xD;
&#xD;
      1.2 Intervention Group&#xD;
&#xD;
      After inclusion in the study and the initial evaluation, the patient will be informed of the&#xD;
      intervention to be submitted. The care nurse will place the catheter fixation device, which&#xD;
      according to the manufacturer, should follow the following instructions:&#xD;
&#xD;
        -  Wash the patient's nose with soap and water that does not release residue;&#xD;
&#xD;
        -  Rinse vigorously and dry thoroughly.&#xD;
&#xD;
        -  Remove the paper that isolates the adhesive barrier (step 1);&#xD;
&#xD;
        -  Position the device so that the fastener is approximately 1 cm below the tip of the&#xD;
           nose. Apply the barrier to the patient's nose, pressing the barrier surface gently&#xD;
           against the skin for 60 seconds (step 2);&#xD;
&#xD;
        -  Fasten the feeding probe, closing the clamp around it, and firmly tighten the arms to&#xD;
           fully engage the serrated teeth (step 3);&#xD;
&#xD;
        -  To remove, raise clamp. Place the tip of one finger over the ledge on the opposite arm&#xD;
           and turn the arm to open (step 4).&#xD;
&#xD;
      The exchange of the device should be every 7 days, in the presence of dirt or if material&#xD;
      deterioration occurs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of accidental enteral probes exit per patient</measure>
    <time_frame>Thirty fifth day</time_frame>
    <description>Will be accessed by the patient's chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reasons for the accidental enteral probes exit per patient and / or reintegration of enteral probes between the groups</measure>
    <time_frame>Thirty fifth day</time_frame>
    <description>Will be accessed by the patient's chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Administrated enteral nutrition volume per patient</measure>
    <time_frame>Thirty fifth day</time_frame>
    <description>The volume of enteral nutrition received will be accessed by the patient's chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of fasting or delay in the use of enteral probes between groups</measure>
    <time_frame>Thirty fifth day</time_frame>
    <description>Time of fasting will be accessed by the patient's chart</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Adult</condition>
  <condition>Enteral Nutrition</condition>
  <condition>Tube Feeding</condition>
  <arm_group>
    <arm_group_label>Interventional Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It consists of the use of the feeding tube attachment device (FTAD) to fix the enteral probe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>It consists of the fixation of the enteral probe with adhesive tape of the micropore type and plaster.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Interventional Group</intervention_name>
    <description>Use of the feeding tube attachment device (FTAD).</description>
    <arm_group_label>Interventional Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults hospitalized in the clinic unit care: 6 sul e 7 norte&#xD;
&#xD;
          -  Use of enteral nutrition in open system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of enteral nutrition by gastrostomy or jejunostomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelli S de Assis, Doctorate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michelli Cristina Silva de Assis</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90690270</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intubation, gastrointestinal</keyword>
  <keyword>nursing</keyword>
  <keyword>clinical trial</keyword>
  <keyword>enteral nutrition</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03262493
org study id: 170217
nct id: NCT03262493
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Enteral nutritional therapy, fed through the gastrointestinal tract via a catheter, tube,
      catheter, or stoma, delivers the nutrients distally to the oral cavity and may reduce
      intrahospital malnutrition. Enteral probes are inserted, at the bedside, through the nose or
      mouth into the stomach or duodenum. Among the main complications of the use enteral probes,
      we can mention: displacement of the probe and administration of diet in the respiratory tract
      or microaspirations. To prevent displacement, enteral probes are attached to the skin on the
      nose or forehead by the use of micropore-type adhesive. In the probe the adhesive tape is put
      in the form of "tie" and again fixed to the nose of the patient. The enteral probes
      displacement rates with this technique are around 62%; in addition, the adhesive tape can
      cause discomfort, nasal necrosis, skin lesions and skin sensitivity reactions to the patient.
      More recently the nasal bridle, an anchor of the enteral feeding tube located around the
      nasal septum or nasal septum, has been described as more effective in securing enteral probes
      position over traditional tape attachment, but is not available in our environment. In
      Brazil, the feeding tube attachment device (FTAD) is available. Until now, the performance of
      FTAD in relation to enteral probe safety and accidental exit rates has not been described in
      the literature. Material's FTAD is composed of a layer of hydrocolloid that is adhered to the
      skin on the back of the nose and a polyurethane clamp that secures the enteral probe. Thus,
      there was a need to evaluate the actual success in using the traditional mode of probe
      attachment. It should be noted that very little scientific evidence is available in the
      literature on such care, and this is due to the lack of well-designed studies on the subject.
Patients will be randomly assigned to the intervention group consisting of the use of the
      feeding tube attachment device (FTAD) or the control group that will use the conventional
      method of attachment with micropore adhesive tape and tape . The data will be compared by
      Student's t test or Mann-Whitney and Pearson's chi-square, according to their distribution.
      The project was approved by the Ethics and Research Committee of the Hospital de Clínicas de
      Porto Alegre. Daily will be accessed through the diet map, available in the hospital
      application, patients who are in use enteral nutrition. These data will be tabulated in the
      screening worksheet, those who meet the eligibility criteria will be invited to participate
      in the study and requested the reading and signing of the informed consent by the patient or
      guardian. The study investigator will inform the allocation group to the guest patient.By
      means of a structured questionnaire, socio demographic and clinical information will be
      collected: age, gender, reason for current hospitalization, comorbidities and information
      related to enteral probe (type of probe, place and date of insertion, number of medications
      in use via enteral probe, type and the date of the last fixation change).

      Traditional fixation with micropore and plaster is routinely performed by the nursing staff
      every 24 hours or whenever necessary. The procedure will be performed as described in the
      study protocol (item 1.1).

      The feeding tube attachment device (FTAD) contains a layer of hydrocolloid that will attach
      to the skin and a clamping clamp around the probe. The placement of the catheter fixation
      device will be performed by the research nurses, these will be previously trained by the
      manufacturer of the material. The fixing procedure is described in item 1.2.

      Patients included will be evaluated daily for study outcomes up to the suspension of enteral
      nutrition prescription, hospital discharge, death or up to 35 days of follow-up. Patients
      starting enteral probe use on Saturday and Sunday can be up to 48 hours with the traditional
      method of fixation and later will be randomized to the intervention or control group.

      1.1 Control Group After inclusion in the study, initial evaluation and information to the
      patient, the attending nurse will follow up on the exchange of the traditional enteral probe
      fixation device that occurs according to the standard operating protocol in the institution
      that recommends micropore fixation according to the "tie" technique and exchange Every 24
      hours and whenever it is loose or with presence of dirt.

      1.2 Intervention Group

      After inclusion in the study and the initial evaluation, the patient will be informed of the
      intervention to be submitted. The care nurse will place the catheter fixation device, which
      according to the manufacturer, should follow the following instructions:

        -  Wash the patient's nose with soap and water that does not release residue;

        -  Rinse vigorously and dry thoroughly.

        -  Remove the paper that isolates the adhesive barrier (step 1);

        -  Position the device so that the fastener is approximately 1 cm below the tip of the
           nose. Apply the barrier to the patient's nose, pressing the barrier surface gently
           against the skin for 60 seconds (step 2);

        -  Fasten the feeding probe, closing the clamp around it, and firmly tighten the arms to
           fully engage the serrated teeth (step 3);

        -  To remove, raise clamp. Place the tip of one finger over the ledge on the opposite arm
           and turn the arm to open (step 4).

      The exchange of the device should be every 7 days, in the presence of dirt or if material
      deterioration occurs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of accidental enteral probes exit per patient
time frame: Thirty fifth day
description: Will be accessed by the patient's chart
measure: Reasons for the accidental enteral probes exit per patient and / or reintegration of enteral probes between the groups
time frame: Thirty fifth day
description: Will be accessed by the patient's chart
measure: Administrated enteral nutrition volume per patient
time frame: Thirty fifth day
description: The volume of enteral nutrition received will be accessed by the patient's chart
measure: Time of fasting or delay in the use of enteral probes between groups
time frame: Thirty fifth day
description: Time of fasting will be accessed by the patient's chart
arm group label: Interventional Group
arm group type: Experimental
description: It consists of the use of the feeding tube attachment device (FTAD) to fix the enteral probe.
arm group label: Conventional Group
arm group type: No Intervention
description: It consists of the fixation of the enteral probe with adhesive tape of the micropore type and plaster.
intervention type: Device
intervention name: Interventional Group
description: Use of the feeding tube attachment device (FTAD).
arm group label: Interventional Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Michelli S de Assis, Doctorate
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
facility: 
country: Brazil
responsible party type: Sponsor
sharing ipd: Undecided