<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/NCT03816748</url>
  </required_header>
  <id_info>
    <org_study_id>201807098RINC</org_study_id>
    <nct_id>NCT03816748</nct_id>
  </id_info>
  <brief_title>The Efficacy of Postoperative Application of HFNC at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients</brief_title>
  <official_title>The Efficacy of Postoperative Application of High Flow Nasal Cannula at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      This is a prospective study that uses the treatment guideline of our chest surgery ICU.&#xD;
      Investigators recruited 90 patients who underwent MIE in the National Taiwan University&#xD;
      Hospital. The clinical data collected included vital signs (blood pressure, heart rate,&#xD;
      respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.),&#xD;
      blood tests, images and bronchoscopic analysis of sputum.&#xD;
&#xD;
      The goal of this study is to analyze common care problems and complications patients may&#xD;
      encounter during the acute stage in ICU after MIE. By comparing the differences between the&#xD;
      treatment group and the control group, investigators can interpret the role of HFNC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, for resectable esophageal cancer lesions, the National Taiwan University&#xD;
      Hospital has developed MIE from the traditional open-abdomen and open-chest reconstructive&#xD;
      surgeries. Because the wounds of minimally invasive surgeries are smaller, most of the&#xD;
      patients can be extubated soon in the operation rooms. During the period when the patients&#xD;
      are sent to ICU for observation, they do not need endotracheal tubes for positive pressure or&#xD;
      sputum suction. Thus, high standards are needed for the inspections of post-operative chest&#xD;
      care, depth of respiration and ability of expectoration in these patients.&#xD;
&#xD;
      The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many&#xD;
      times higher than the traditional nasal cannula. In addition, HFNC provides heating and&#xD;
      moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out.&#xD;
      This way, the patients can wear HFNC continuously for many days. Furthermore, when the&#xD;
      patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung&#xD;
      expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.&#xD;
&#xD;
      This is a prospective study that uses the treatment guideline of our chest surgery ICU.&#xD;
      Investigators recruited 60 patients who underwent MIE in the National Taiwan University&#xD;
      Hospital between January 2018 and December 2018. The clinical data collected included vital&#xD;
      signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood&#xD;
      oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.&#xD;
&#xD;
      The goal of this study is to analyze common care problems and complications patients may&#xD;
      encounter during the acute stage in ICU after MIE. By comparing the differences between the&#xD;
      treatment group and the control group, investigators can interpret the role of HFNC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygenation</measure>
    <time_frame>Post-operative 24 hours - 72 hours</time_frame>
    <description>saturation of blood oxygen and carbon dioxide by blood gas analyzer</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept HFNC treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal cannula, HFNC</intervention_name>
    <description>The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of esophageal cancer. Underwent minimally invasive esophagectomy&#xD;
        surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. The patient return to the intensive care unit without extubation 2. The patient who&#xD;
        underwent tracheostomy surgery 3. Blood loss more than 1000c.c during the surgery 4. The&#xD;
        patient who underwent CPR procedure or other emergent resuscitation management during&#xD;
        surgery 5. The patient who is unable to communicate in words or speech&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HSIEN-CHI LIAO, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Minimally invasive surgery</keyword>
  <keyword>High flow nasal cannula</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03816748/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03816748
org study id: 201807098RINC
nct id: NCT03816748
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective study that uses the treatment guideline of our chest surgery ICU.
      Investigators recruited 90 patients who underwent MIE in the National Taiwan University
      Hospital. The clinical data collected included vital signs (blood pressure, heart rate,
      respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.),
      blood tests, images and bronchoscopic analysis of sputum.

      The goal of this study is to analyze common care problems and complications patients may
      encounter during the acute stage in ICU after MIE. By comparing the differences between the
      treatment group and the control group, investigators can interpret the role of HFNC.
In recent years, for resectable esophageal cancer lesions, the National Taiwan University
      Hospital has developed MIE from the traditional open-abdomen and open-chest reconstructive
      surgeries. Because the wounds of minimally invasive surgeries are smaller, most of the
      patients can be extubated soon in the operation rooms. During the period when the patients
      are sent to ICU for observation, they do not need endotracheal tubes for positive pressure or
      sputum suction. Thus, high standards are needed for the inspections of post-operative chest
      care, depth of respiration and ability of expectoration in these patients.

      The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many
      times higher than the traditional nasal cannula. In addition, HFNC provides heating and
      moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out.
      This way, the patients can wear HFNC continuously for many days. Furthermore, when the
      patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung
      expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.

      This is a prospective study that uses the treatment guideline of our chest surgery ICU.
      Investigators recruited 60 patients who underwent MIE in the National Taiwan University
      Hospital between January 2018 and December 2018. The clinical data collected included vital
      signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood
      oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.

      The goal of this study is to analyze common care problems and complications patients may
      encounter during the acute stage in ICU after MIE. By comparing the differences between the
      treatment group and the control group, investigators can interpret the role of HFNC.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Oxygenation
time frame: Post-operative 24 hours - 72 hours
description: saturation of blood oxygen and carbon dioxide by blood gas analyzer
arm group label: intervention
arm group type: Experimental
description: Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept HFNC treatment
arm group label: control
arm group type: No Intervention
description: Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept usual care
intervention type: Device
intervention name: High flow nasal cannula, HFNC
description: The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.
arm group label: intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: HSIEN-CHI LIAO, M.D.
role: Study Director
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: No
provided document: 