<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/NCT03828578</url>
  </required_header>
  <id_info>
    <org_study_id>223048</org_study_id>
    <nct_id>NCT03828578</nct_id>
  </id_info>
  <brief_title>Comparison of AIRVO High Flow Oxygen Therapy With Standard Care for Prevention of PPCs After Major H&amp;N Surgery</brief_title>
  <official_title>Comparison of AIRVO High Flow Oxygen Therapy With Standard Care for Prevention of Post-operative Pulmonary Complications After Major Head and Neck Surgery Involving Insertion of a Tracheostomy - A Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff and Vale University Health Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiff and Vale University Health Board</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>
      Patients undergoing major head and neck surgery often develop breathing difficulties as a&#xD;
      result of build up of sputum and difficulty taking deep breaths. Often as part of the surgery&#xD;
      patients may also require a tracheotomy tube (a temporary tube placed into their airway)&#xD;
      which is removed around 5-7 days after the operation. The presence of this tracheostomy tube&#xD;
      increases the patient's risk of developing breathing problems, especially difficulty clearing&#xD;
      sputum and reduced lung volumes. To reduce the risk of developing these problems, different&#xD;
      forms of oxygen therapy and humidification are used. This normally involves using oxygen&#xD;
      masks, nebulisers and other medications to help loosen the sputum and maintain blood oxygen&#xD;
      levels. Another method of giving oxygen and humidification is through the use of AIRVO, which&#xD;
      delivers the air / oxygen to the patient at higher rates as well as warming and humidifying&#xD;
      the air.&#xD;
&#xD;
      The aim of this study is to compare the AIRVO system to standard care in a small sample of&#xD;
      patients (20 patients) undergoing major head and neck surgery involving insertion of a&#xD;
      tracheostomy tube.&#xD;
&#xD;
      The study will compare rates of breathing complications (e.g. pneumonia, reduced lung volume)&#xD;
      as well as comparing the time to remove the tracheostomy tube and the time the patient is&#xD;
      required to stay in hospital. These results will then be used to develop a larger funded&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Major head and neck surgery involving micro-vascular reconstructions are prolonged procedures&#xD;
      with considerable post operative risk. Not only do patients have prolonged time in theatre,&#xD;
      the surgery involves two distinct surgical sites (head &amp; neck site and peripheral flap donor&#xD;
      site), and requires the patient to be admitted to a high care area for overnight sedation and&#xD;
      ventilation. This combined with the presence of significant co-morbidities such as&#xD;
      hypertension, cardiomyopathy and respiratory disease, place the patient at significant risk&#xD;
      of post-operative complications. A recent prospective cohort study reported complication&#xD;
      rates in nearly 65% of cases, of which 29% were of pulmonary origin. Furthermore, of these,&#xD;
      14 patients required treatment in the intensive care or high dependency. Interestingly, and&#xD;
      in contrast to other research3, neither pre-operative smoking nor the presence of&#xD;
      pre-existing lung disease predicted pulmonary complications.&#xD;
&#xD;
      The risks of post-operative pulmonary complications (PPCs) seem to be further increased in&#xD;
      those patients requiring a tracheostomy. This tracheostomy is required to facilitate access&#xD;
      to the tumour location and to provide post-operative airway protection in the presence of&#xD;
      significant swelling or oedema. The risks of tracheostomy are well known4. Patients are prone&#xD;
      to increased rates of infection, poor sputum clearance and inadequate humidification. These&#xD;
      complications lead to prolonged admissions, delays in tracheostomy weaning and considerable&#xD;
      healthcare related costs. To overcome these issues national guidance documents have&#xD;
      identified the need to provide adequate humidification to prevent mucus plugging, as well as&#xD;
      the provision of increased nursing care for stoma site cleaning and inner tube care.&#xD;
      Historically, humidification has been provided by heated systems however due to perceived&#xD;
      increased infection risk this has fallen out of favour and now passive humidification systems&#xD;
      such as heat moisture exchangers have become more popular.&#xD;
&#xD;
      Clearly, the combination of the risks of major head and neck surgery and those of a&#xD;
      tracheostomy, place the patient at significant risk. As such it is essential to develop new&#xD;
      post-operative management protocols to reduce the occurrence of post-operative complications.&#xD;
&#xD;
      AIRVOTM (a form of non-invasive high flow oxygen therapy, HFOT), which delivers high flow&#xD;
      heated and humidified oxygen and air via a tracheostomy tube at a prescribed fraction of&#xD;
      inspired oxygen and a maximum flow of 60 L/min, is an attractive alternative to conventional&#xD;
      oxygen therapy. Previous studies have shown that HFOT therapy generates a flow-dependent&#xD;
      positive airway pressure and improves oxygenation by increasing end-expiratory lung volume,&#xD;
      thus suggesting a possible alveolar recruitment associated with high-flow therapy. Although&#xD;
      widely used in other clinical areas including patients with tracheostomy tubes, HFOT&#xD;
      delivered in the AIRVOTM system has yet to be evaluated in the Head and Neck surgery&#xD;
      population.&#xD;
&#xD;
      This study aims to compare the effects of application of HFOT(delivered via AIRVOTM) therapy&#xD;
      and conventional oxygen and humidification administration after major head and neck surgery&#xD;
      involving insertion of a tracheostomy tube on postoperative pulmonary complications. The&#xD;
      study will also compare post-operative length of stay, time to tracheostomy tube cuff&#xD;
      deflation, tracheostomy tube decannulation, antibiotic use and post-operative physiotherapy&#xD;
      requirements.&#xD;
&#xD;
      The results of this proof of concept study will be used to further develop local protocols&#xD;
      and to inform a grant funded multi-centre trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants diagnosed with post-operative Pulmonary Complications</measure>
    <time_frame>Up to 48hours post tracheostomy decannulation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to decannulation</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Measured in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Measured in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of physiotherapy intervention recieved by each participant</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Measured in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasability of recruitment, randomisation, delivery of intervention, and completion of outcome measures</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Measured in percentages</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>High flow oxygen therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the intervention group will receive high flow oxygen therapy via the tracheostomy tube from cessation of mechanical ventilation. The HFOT will provide oxygen therapy at a flow rate of 50-60 litres per minute at a FiO2 titrated by the bedside clinician to maintain a peripheral oxygen saturation of 95% of more (unless otherwise clinically indicated and documented by an appropriate consultant).&#xD;
Once transferred to the ward patients will continue to receive HFOT 24 hours per day at a rate of 50-60 litres per minute at a maximum oxygen concentration of 40% to achieve oxygen saturations 95% and above (unless otherwise documented).&#xD;
Patients may be disconnected from the HFOT for short periods for toileting, mobilising etc. Tracheostomy weaning will continue as per standard practice with an aim of cuff deflation followed by decannulation once clinically appropriate. systems. Following decannulation patients will resort to standard oxygen therapy as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomised to the standard care study arm will receive routine post-operative care as currently performed within the host organisation. Following cessation of mechanical ventilation, oxygen therapy will be delivered using equipment and rates appropriate to the clinical picture. On transfer to the ward patients will continue with existing methods of oxygen therapy and will be weaned from these accordingly. Patients will continue to use heat moisture exchanges (e.g. Swedish nose or Buchannan protectors) as clinically indicated, as well as having saline nebulisers prescribed and administered as per standard. Tracheostomy weaning will continue in accordance with current practice. Data on all of the applied procedures will be recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High flow oxygen therapy</intervention_name>
    <description>High flow oxygen therapy delivered via Airvo2</description>
    <arm_group_label>High flow oxygen therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing head and neck surgery with microvascular reconstruction and involving&#xD;
             insertion of a tracheostomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old&#xD;
&#xD;
          -  Lack of consent&#xD;
&#xD;
          -  Consultant request&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiff and Vale University Health Board</name>
      <address>
        <city>Cardiff</city>
        <zip>CF144XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiff and Vale University Health Board</investigator_affiliation>
    <investigator_full_name>Paul Twose</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</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/NCT03828578
org study id: 223048
nct id: NCT03828578
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients undergoing major head and neck surgery often develop breathing difficulties as a
      result of build up of sputum and difficulty taking deep breaths. Often as part of the surgery
      patients may also require a tracheotomy tube (a temporary tube placed into their airway)
      which is removed around 5-7 days after the operation. The presence of this tracheostomy tube
      increases the patient's risk of developing breathing problems, especially difficulty clearing
      sputum and reduced lung volumes. To reduce the risk of developing these problems, different
      forms of oxygen therapy and humidification are used. This normally involves using oxygen
      masks, nebulisers and other medications to help loosen the sputum and maintain blood oxygen
      levels. Another method of giving oxygen and humidification is through the use of AIRVO, which
      delivers the air / oxygen to the patient at higher rates as well as warming and humidifying
      the air.

      The aim of this study is to compare the AIRVO system to standard care in a small sample of
      patients (20 patients) undergoing major head and neck surgery involving insertion of a
      tracheostomy tube.

      The study will compare rates of breathing complications (e.g. pneumonia, reduced lung volume)
      as well as comparing the time to remove the tracheostomy tube and the time the patient is
      required to stay in hospital. These results will then be used to develop a larger funded
      study.
Major head and neck surgery involving micro-vascular reconstructions are prolonged procedures
      with considerable post operative risk. Not only do patients have prolonged time in theatre,
      the surgery involves two distinct surgical sites (head & neck site and peripheral flap donor
      site), and requires the patient to be admitted to a high care area for overnight sedation and
      ventilation. This combined with the presence of significant co-morbidities such as
      hypertension, cardiomyopathy and respiratory disease, place the patient at significant risk
      of post-operative complications. A recent prospective cohort study reported complication
      rates in nearly 65% of cases, of which 29% were of pulmonary origin. Furthermore, of these,
      14 patients required treatment in the intensive care or high dependency. Interestingly, and
      in contrast to other research3, neither pre-operative smoking nor the presence of
      pre-existing lung disease predicted pulmonary complications.

      The risks of post-operative pulmonary complications (PPCs) seem to be further increased in
      those patients requiring a tracheostomy. This tracheostomy is required to facilitate access
      to the tumour location and to provide post-operative airway protection in the presence of
      significant swelling or oedema. The risks of tracheostomy are well known4. Patients are prone
      to increased rates of infection, poor sputum clearance and inadequate humidification. These
      complications lead to prolonged admissions, delays in tracheostomy weaning and considerable
      healthcare related costs. To overcome these issues national guidance documents have
      identified the need to provide adequate humidification to prevent mucus plugging, as well as
      the provision of increased nursing care for stoma site cleaning and inner tube care.
      Historically, humidification has been provided by heated systems however due to perceived
      increased infection risk this has fallen out of favour and now passive humidification systems
      such as heat moisture exchangers have become more popular.

      Clearly, the combination of the risks of major head and neck surgery and those of a
      tracheostomy, place the patient at significant risk. As such it is essential to develop new
      post-operative management protocols to reduce the occurrence of post-operative complications.

      AIRVOTM (a form of non-invasive high flow oxygen therapy, HFOT), which delivers high flow
      heated and humidified oxygen and air via a tracheostomy tube at a prescribed fraction of
      inspired oxygen and a maximum flow of 60 L/min, is an attractive alternative to conventional
      oxygen therapy. Previous studies have shown that HFOT therapy generates a flow-dependent
      positive airway pressure and improves oxygenation by increasing end-expiratory lung volume,
      thus suggesting a possible alveolar recruitment associated with high-flow therapy. Although
      widely used in other clinical areas including patients with tracheostomy tubes, HFOT
      delivered in the AIRVOTM system has yet to be evaluated in the Head and Neck surgery
      population.

      This study aims to compare the effects of application of HFOT(delivered via AIRVOTM) therapy
      and conventional oxygen and humidification administration after major head and neck surgery
      involving insertion of a tracheostomy tube on postoperative pulmonary complications. The
      study will also compare post-operative length of stay, time to tracheostomy tube cuff
      deflation, tracheostomy tube decannulation, antibiotic use and post-operative physiotherapy
      requirements.

      The results of this proof of concept study will be used to further develop local protocols
      and to inform a grant funded multi-centre trial.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of participants diagnosed with post-operative Pulmonary Complications
time frame: Up to 48hours post tracheostomy decannulation
measure: Time to decannulation
time frame: Up to 4 weeks
description: Measured in days
measure: Hospital length of stay
time frame: Up to 4 weeks
description: Measured in days
measure: Amount of physiotherapy intervention recieved by each participant
time frame: Up to 4 weeks
description: Measured in minutes
measure: Feasability of recruitment, randomisation, delivery of intervention, and completion of outcome measures
time frame: Up to 4 weeks
description: Measured in percentages
arm group label: High flow oxygen therapy
arm group type: Experimental
description: Patients allocated to the intervention group will receive high flow oxygen therapy via the tracheostomy tube from cessation of mechanical ventilation. The HFOT will provide oxygen therapy at a flow rate of 50-60 litres per minute at a FiO2 titrated by the bedside clinician to maintain a peripheral oxygen saturation of 95% of more (unless otherwise clinically indicated and documented by an appropriate consultant).
Once transferred to the ward patients will continue to receive HFOT 24 hours per day at a rate of 50-60 litres per minute at a maximum oxygen concentration of 40% to achieve oxygen saturations 95% and above (unless otherwise documented).
Patients may be disconnected from the HFOT for short periods for toileting, mobilising etc. Tracheostomy weaning will continue as per standard practice with an aim of cuff deflation followed by decannulation once clinically appropriate. systems. Following decannulation patients will resort to standard oxygen therapy as needed.
arm group label: Standard Care
arm group type: No Intervention
description: Patients randomised to the standard care study arm will receive routine post-operative care as currently performed within the host organisation. Following cessation of mechanical ventilation, oxygen therapy will be delivered using equipment and rates appropriate to the clinical picture. On transfer to the ward patients will continue with existing methods of oxygen therapy and will be weaned from these accordingly. Patients will continue to use heat moisture exchanges (e.g. Swedish nose or Buchannan protectors) as clinically indicated, as well as having saline nebulisers prescribed and administered as per standard. Tracheostomy weaning will continue in accordance with current practice. Data on all of the applied procedures will be recorded.
intervention type: Procedure
intervention name: High flow oxygen therapy
description: High flow oxygen therapy delivered via Airvo2
arm group label: High flow oxygen therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cardiff and Vale University Health Board
investigator full name: Paul Twose
investigator title: Physiotherapist
mesh term: Head and Neck Neoplasms
sharing ipd: No