<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/NCT04462497</url>
  </required_header>
  <id_info>
    <org_study_id>2019/00637</org_study_id>
    <nct_id>NCT04462497</nct_id>
  </id_info>
  <brief_title>Chest-Up: Obtaining Safe Positioning for Thoracic Surgery</brief_title>
  <official_title>Chest-Up: Obtaining Safe Positioning for Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>No</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>
      Thoracotomy surgeries, both open and video assisted, are often carried out in the lateral&#xD;
      decubitus position to optimize surgical access to the operative side. However, this position&#xD;
      is also associated with mechanical injuries of the shoulder joint ligaments and pulling on&#xD;
      the structures of the brachial plexus. The neck is laterally flexed and has potential to&#xD;
      cause mechanical injury as well due to the dependent position of the patient's head.&#xD;
&#xD;
      The current method of positioning involves stacking of towels under a head support. To the&#xD;
      study team's knowledge, no pre-formed head and neck support exists that can cope with the&#xD;
      required surgical position. Thus, the study team has conceptualized an adaptive head and neck&#xD;
      support pillow to meet this need and address patient safety concerns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thoracotomy surgeries, both open and video assisted, are often carried out in the lateral&#xD;
      decubitus position. This necessitates the flexion of the surgical table into an inversed 'v'&#xD;
      shape to optimize surgical access to the operative side.&#xD;
&#xD;
      However, this position is also associated with mechanical injuries of the shoulder joint&#xD;
      ligaments and pulling on the structures of the brachial plexus. With the dependent position&#xD;
      of the patient's head, the neck is laterally flexed and has potential to cause mechanical&#xD;
      injury as well. Normal cervical flexion range of motion is about 20-45 degrees, although this&#xD;
      may be restricted in patients with cervical spine pathology or in the elderly. Ipsilateral&#xD;
      shoulder pain (ISP) post thoracic surgery is a recognized complication and can be difficult&#xD;
      to treat. While referred pain from the phrenic nerve is the well-studied cause, some&#xD;
      literature noted that ipsilateral shoulder pain of the musculoskeletal type is more intense&#xD;
      than referred ipsilateral shoulder pain. Rarer complications are not well reported but may&#xD;
      include paraplegia and winging of the scapula. Positioning is also more challenging in obese&#xD;
      patients, accompanied by a higher risk of position related complications.&#xD;
&#xD;
      The current method of positioning involves stacking of towels under a head support. To the&#xD;
      study team's knowledge, no pre-formed head and neck support exists that can cope with the&#xD;
      required surgical position, movements during the flexing and unflexing of the surgical table,&#xD;
      as well as the different physical attributes of different patients.&#xD;
&#xD;
      The study team is concerned regarding the inherent dangers to patient safety, such as&#xD;
      slippage or instability of a stack of towels, and the need for at least 3 personnel to help&#xD;
      support the patient's head and neck adequately during positioning. With the anaesthetist&#xD;
      preoccupied with holding the patient's head during positioning, there is the potential for&#xD;
      inattention to other important issues such as haemodynamic changes. Existing methods of using&#xD;
      a bean bag have fallen out of favor in our institution due to restriction of surgical access,&#xD;
      bulkiness of the bean bag, need for a suction pump, and risk of pressure injury. The bean&#xD;
      bag's main application is for maintaining the body in a lateral position, not for head and&#xD;
      neck support.&#xD;
&#xD;
      Hence, the study team conceptualized the adaptive head and neck support pillow to meet this&#xD;
      need and address patient safety concerns. Beyond thoracic surgery, it is hoped it will have&#xD;
      applications in other situations requiring lateral decubitus positioning with flexion of the&#xD;
      surgical table, such as nephrectomies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 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>There will be 2 groups of a patients randomized to either the existing method of head support (sponge and towel stack) or prototype head and neck support device.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>One group of patients will receive the existing method of head support (control group), the other group will receive the prototype head and neck support device (study group)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Degrees of flexion during positioning</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>During positioning of patient, the goniometer will be used to measure and record the degree of lateral neck movement during the positioning process. Degrees of deviation from the maximum comfortable degree of the patient's lateral flexion calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative follow-up</measure>
    <time_frame>Postoperative days 1 and 2</time_frame>
    <description>Patient will be contacted on postoperative day 1 and 2 to ask about neck or shoulder pain, numbness or weakness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Satisfaction</measure>
    <time_frame>Immediate postoperative</time_frame>
    <description>Gather user satisfaction feedback from surgeons and anaesthetists regarding usability and satisfaction using a Likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Thoracic</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive the existing method of head support (sponge and towel stack) intraoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the prototype head and neck support device intraoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prototype device</intervention_name>
    <description>Patients will receive the prototype head and neck support device to be used intraoperatively.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 years and above&#xD;
&#xD;
          -  Listed for elective thoracic surgery in the lateral decubitus position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Age below 21 years&#xD;
&#xD;
          -  Emergency cases&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Cognitively impaired patients&#xD;
&#xD;
          -  Unconscious patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xian Li Deborah Khoo</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xian Li Deborah Khoo</last_name>
    <phone>97585794</phone>
    <email>deborah_khoo@nuhs.edu.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Theng Wai Foong</last_name>
    <phone>96209087</phone>
    <email>theng_wai_foong@nuhs.edu.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xian Li Deborah Khoo</last_name>
      <phone>97585794</phone>
      <email>deborah_khoo@nuhs.edu.sg</email>
    </contact>
    <investigator>
      <last_name>Dr Xian Li Deborah Khoo</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dr Theng Wai Foong</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Blichfeldt-Eckhardt MR, Andersen C, Ording H, Licht PB, Toft P. Shoulder Pain After Thoracic Surgery: Type and Time Course, a Prospective Cohort Study. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):147-151. doi: 10.1053/j.jvca.2016.04.032. Epub 2016 May 9.</citation>
    <PMID>27576216</PMID>
  </reference>
  <reference>
    <citation>Yousefshahi F, Predescu O, Colizza M, Asenjo JF. Postthoracotomy Ipsilateral Shoulder Pain: A Literature Review on Characteristics and Treatment. Pain Res Manag. 2016;2016:3652726. doi: 10.1155/2016/3652726. Epub 2016 Nov 28.</citation>
    <PMID>28018130</PMID>
  </reference>
  <reference>
    <citation>Bhuiyan MS, Mallick A, Parsloe M. Post-thoracotomy paraplegia coincident with epidural anaesthesia. Anaesthesia. 1998 Jun;53(6):583-6. doi: 10.1046/j.1365-2044.1998.00470.x.</citation>
    <PMID>9709146</PMID>
  </reference>
  <reference>
    <citation>Martin JT. Postoperative isolated dysfunction of the long thoracic nerve: a rare entity of uncertain etiology. Anesth Analg. 1989 Nov;69(5):614-9.</citation>
    <PMID>2552867</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraoperative</keyword>
  <keyword>Lateral decubitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04462497
org study id: 2019/00637
nct id: NCT04462497
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thoracotomy surgeries, both open and video assisted, are often carried out in the lateral
      decubitus position to optimize surgical access to the operative side. However, this position
      is also associated with mechanical injuries of the shoulder joint ligaments and pulling on
      the structures of the brachial plexus. The neck is laterally flexed and has potential to
      cause mechanical injury as well due to the dependent position of the patient's head.

      The current method of positioning involves stacking of towels under a head support. To the
      study team's knowledge, no pre-formed head and neck support exists that can cope with the
      required surgical position. Thus, the study team has conceptualized an adaptive head and neck
      support pillow to meet this need and address patient safety concerns.
Thoracotomy surgeries, both open and video assisted, are often carried out in the lateral
      decubitus position. This necessitates the flexion of the surgical table into an inversed 'v'
      shape to optimize surgical access to the operative side.

      However, this position is also associated with mechanical injuries of the shoulder joint
      ligaments and pulling on the structures of the brachial plexus. With the dependent position
      of the patient's head, the neck is laterally flexed and has potential to cause mechanical
      injury as well. Normal cervical flexion range of motion is about 20-45 degrees, although this
      may be restricted in patients with cervical spine pathology or in the elderly. Ipsilateral
      shoulder pain (ISP) post thoracic surgery is a recognized complication and can be difficult
      to treat. While referred pain from the phrenic nerve is the well-studied cause, some
      literature noted that ipsilateral shoulder pain of the musculoskeletal type is more intense
      than referred ipsilateral shoulder pain. Rarer complications are not well reported but may
      include paraplegia and winging of the scapula. Positioning is also more challenging in obese
      patients, accompanied by a higher risk of position related complications.

      The current method of positioning involves stacking of towels under a head support. To the
      study team's knowledge, no pre-formed head and neck support exists that can cope with the
      required surgical position, movements during the flexing and unflexing of the surgical table,
      as well as the different physical attributes of different patients.

      The study team is concerned regarding the inherent dangers to patient safety, such as
      slippage or instability of a stack of towels, and the need for at least 3 personnel to help
      support the patient's head and neck adequately during positioning. With the anaesthetist
      preoccupied with holding the patient's head during positioning, there is the potential for
      inattention to other important issues such as haemodynamic changes. Existing methods of using
      a bean bag have fallen out of favor in our institution due to restriction of surgical access,
      bulkiness of the bean bag, need for a suction pump, and risk of pressure injury. The bean
      bag's main application is for maintaining the body in a lateral position, not for head and
      neck support.

      Hence, the study team conceptualized the adaptive head and neck support pillow to meet this
      need and address patient safety concerns. Beyond thoracic surgery, it is hoped it will have
      applications in other situations requiring lateral decubitus positioning with flexion of the
      surgical table, such as nephrectomies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There will be 2 groups of a patients randomized to either the existing method of head support (sponge and towel stack) or prototype head and neck support device.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: One group of patients will receive the existing method of head support (control group), the other group will receive the prototype head and neck support device (study group)
measure: Degrees of flexion during positioning
time frame: Intraoperatively
description: During positioning of patient, the goniometer will be used to measure and record the degree of lateral neck movement during the positioning process. Degrees of deviation from the maximum comfortable degree of the patient's lateral flexion calculated.
measure: Post-operative follow-up
time frame: Postoperative days 1 and 2
description: Patient will be contacted on postoperative day 1 and 2 to ask about neck or shoulder pain, numbness or weakness.
measure: User Satisfaction
time frame: Immediate postoperative
description: Gather user satisfaction feedback from surgeons and anaesthetists regarding usability and satisfaction using a Likert scale.
arm group label: Control Group
arm group type: No Intervention
description: Participants will receive the existing method of head support (sponge and towel stack) intraoperatively.
arm group label: Study Group
arm group type: Experimental
description: Participants will receive the prototype head and neck support device intraoperatively.
intervention type: Other
intervention name: Prototype device
description: Patients will receive the prototype head and neck support device to be used intraoperatively.
arm group label: Study Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Xian Li Deborah Khoo
role: Principal Investigator
affiliation: National University Hospital, Singapore
last name: Xian Li Deborah Khoo
phone: 97585794
email: deborah_khoo@nuhs.edu.sg
last name: Theng Wai Foong
phone: 96209087
email: theng_wai_foong@nuhs.edu.sg
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Singapore
citation: Blichfeldt-Eckhardt MR, Andersen C, Ording H, Licht PB, Toft P. Shoulder Pain After Thoracic Surgery: Type and Time Course, a Prospective Cohort Study. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):147-151. doi: 10.1053/j.jvca.2016.04.032. Epub 2016 May 9.
PMID: 27576216
citation: Yousefshahi F, Predescu O, Colizza M, Asenjo JF. Postthoracotomy Ipsilateral Shoulder Pain: A Literature Review on Characteristics and Treatment. Pain Res Manag. 2016;2016:3652726. doi: 10.1155/2016/3652726. Epub 2016 Nov 28.
PMID: 28018130
citation: Bhuiyan MS, Mallick A, Parsloe M. Post-thoracotomy paraplegia coincident with epidural anaesthesia. Anaesthesia. 1998 Jun;53(6):583-6. doi: 10.1046/j.1365-2044.1998.00470.x.
PMID: 9709146
citation: Martin JT. Postoperative isolated dysfunction of the long thoracic nerve: a rare entity of uncertain etiology. Anesth Analg. 1989 Nov;69(5):614-9.
PMID: 2552867
responsible party type: Sponsor
mesh term: Aortic Dissection
sharing ipd: No