<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/NCT04479332</url>
  </required_header>
  <id_info>
    <org_study_id>202005094RIND</org_study_id>
    <nct_id>NCT04479332</nct_id>
  </id_info>
  <brief_title>The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)</brief_title>
  <official_title>The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)</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>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>
      In the ER of National Taiwan University Hospital, the critical patients are treated&#xD;
      (including tracheal intubation and cardiopulmonary resuscitation) in either resuscitation&#xD;
      area or negative pressure isolation rooms based on the past history and present illness.&#xD;
      During COVID-19 epidemic, whether sequential changes in environmental and personal protective&#xD;
      equipment would change the difference of treatment efficacy and patient safety remains&#xD;
      unclear. Whether treating patients in resuscitation area or negative pressure isolation room&#xD;
      would cause different physical and psychological stress of medical staff and environmental&#xD;
      contamination is also unknown. This study aims to conduct a prospective sequential allocation&#xD;
      clinical trial to investigate the success rate, patient safety, physical and psychological&#xD;
      stress of medical staff, and the risk of environmental contamination of tracheal intubation&#xD;
      and cardiopulmonary resuscitation between the resuscitation area and negative pressure&#xD;
      isolation room. The results of the study may be used to improve the protocol and protective&#xD;
      policy in treating critical patients during an epidemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The critical care of patients with an emergency has always been the clinical challenge to the&#xD;
      medical staff in the emergency room (ER). The emergency includes sudden cardiac arrest,&#xD;
      respiratory failure, acute conscious change, cardiovascular emergency, sepsis, etc. How to&#xD;
      treat these patients appropriately and immediately is an important issue, which may change&#xD;
      the disease process and prognosis, and save the life.&#xD;
&#xD;
      Owing to the epidemic of coronavirus disease 19 (COVID-19), several changes in the&#xD;
      environmental and personal protective equipment have been made in the ER when treating&#xD;
      critical patients. The doctor and nurses need to wear individual protective equipment&#xD;
      including Level C protective clothing, goggles, N95 mask, surgical mask, guard panel, hair&#xD;
      cap, and double-layered gloves to prevent infectious droplet during tracheal intubation.&#xD;
      However, the protective equipment may limit the movement and obstruct the vision and thus&#xD;
      result in response delays, difficult intubation, and prolong hand-off period during&#xD;
      cardiopulmonary resuscitation. On the other hand, wearing N95 mask, surgical mask and guard&#xD;
      panel may impair the communication. Additionally, the medical staff may not have enough time&#xD;
      to wear the protective equipment during emergency events, and therefore suffer from a higher&#xD;
      risk of infection, which may consequently cause a certain level of psychological stress.&#xD;
&#xD;
      This study aims to conduct a prospective sequential allocation clinical trial to investigate&#xD;
      the success rate, patient safety, physical and psychological stress of medical staff, and the&#xD;
      risk of environmental contamination of tracheal intubation and cardiopulmonary resuscitation&#xD;
      between the resuscitation area and negative pressure isolation room. The results of the study&#xD;
      may be used to improve the protocol and protective policy in treating critical patients&#xD;
      during an epidemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Actual">February 23, 2021</completion_date>
  <primary_completion_date type="Actual">February 23, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison between the duration and number of tries needed to intubate a patient, or achieve ROSC in patients requiring cardiopulmonary resuscitation, in resuscitation area and negative pressure isolation rooms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The patient prognosis between resuscitation area and negative pressure isolation rooms</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison between the survival rate of patients who were intubated in the resuscitation area and negative pressure isolation rooms, taking into account the duration of hospital stay, respiratory status (successful extubation, post tracheostomy, etc), and neurological state (using the Glasgow coma score, cerebral performance categories, and overall performance categories) upon discharge from the hospital.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The physical and psychological stress of medical staff</measure>
    <time_frame>14 days</time_frame>
    <description>The medical staff involved in the intubation and/or cardiopulmonary resuscitation procedures will be asked to voluntarily fill up a survey form to determine their level of psychological stress. They will also be followed up within 14 days post exposure for covid-19 symptoms and undergo testing and quarantine if needed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The amount of environmental contamination between resuscitation area and negative pressure isolation rooms</measure>
    <time_frame>14 days</time_frame>
    <description>The facilities in both resuscitation area and negative pressure isolation rooms will be sampled and compared for the presence of the coronavirus after each intubation or cardiopulmonary resuscitation procedure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Resuscitation Area</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Critical patient is assigned to the resuscitation area for treatment under medical staff on personal protective equipment; Manpower distribution during tracheal intubation: 1-2 licensed physicians, 2-3 nurses (1 for preparing intubation materials and acts as the assist, 1-2 for administering medications and documentation); Manpower distribution during cardiopulmonary resuscitation: 2 licensed physicians (1 inside resuscitation area, 1 at nurses' station), 4 nurses (2 inside resuscitation area, 2 at the sterile area)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Pressure Isolation Room</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Critical patient is assigned to the negative pressure isolation room for treatment under medical staff on personal protective equipment; Manpower distribution during tracheal intubation: 1 licensed physician, 2 nurses (1 for preparing intubation materials, acts as the assist, and for administering medications; 1 for documentation at the anteroom); Manpower distribution during cardiopulmonary resuscitation: 2 licensed physicians (1 inside negative pressure isolation room, 1 at nurses' station), 5 nurses (2 inside negative pressure isolation room, 1 at the anteroom, 2 at the sterile area)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tracheal intubation and cardiopulmonary resuscitation</intervention_name>
    <description>Critical patients at the emergency room who require tracheal intubation and/or cardiopulmonary resuscitation will be sequentially allocated to either the resuscitation area or negative pressure isolation room for treatment by the designated medical staff wearing personal protective equipment.</description>
    <arm_group_label>Negative Pressure Isolation Room</arm_group_label>
    <arm_group_label>Resuscitation Area</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Critical Care Patients:&#xD;
&#xD;
          -  showing respiratory distress&#xD;
&#xD;
          -  require airway protection&#xD;
&#xD;
          -  EOC notified of an out-of-hospital cardiac arrest&#xD;
&#xD;
        Exclusion Criteria for Critical Care Patients:&#xD;
&#xD;
          -  age less than 20 years old&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  in-hospital cardiac arrest in patients prior to intubation&#xD;
&#xD;
          -  confirmed cases of covid-19 prior to intubation&#xD;
&#xD;
          -  patient or patient's family refuses the procedure&#xD;
&#xD;
        Inclusion Criteria for Medical Staff:&#xD;
&#xD;
          -  staff who attended index intubation or resuscitation are encouraged to answer the&#xD;
             survey form&#xD;
&#xD;
        Exclusion Criteria for Medical Staff:&#xD;
&#xD;
          -  none&#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>Min-Shan Tsai, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus disease 19 (COVID-19)</keyword>
  <keyword>Critical care</keyword>
  <keyword>Endotracheal intubation</keyword>
  <keyword>Cardiopulmonary resuscitation</keyword>
  <keyword>Stress</keyword>
  <keyword>Environment contamination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- 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/NCT04479332
org study id: 202005094RIND
nct id: NCT04479332
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the ER of National Taiwan University Hospital, the critical patients are treated
      (including tracheal intubation and cardiopulmonary resuscitation) in either resuscitation
      area or negative pressure isolation rooms based on the past history and present illness.
      During COVID-19 epidemic, whether sequential changes in environmental and personal protective
      equipment would change the difference of treatment efficacy and patient safety remains
      unclear. Whether treating patients in resuscitation area or negative pressure isolation room
      would cause different physical and psychological stress of medical staff and environmental
      contamination is also unknown. This study aims to conduct a prospective sequential allocation
      clinical trial to investigate the success rate, patient safety, physical and psychological
      stress of medical staff, and the risk of environmental contamination of tracheal intubation
      and cardiopulmonary resuscitation between the resuscitation area and negative pressure
      isolation room. The results of the study may be used to improve the protocol and protective
      policy in treating critical patients during an epidemic.
The critical care of patients with an emergency has always been the clinical challenge to the
      medical staff in the emergency room (ER). The emergency includes sudden cardiac arrest,
      respiratory failure, acute conscious change, cardiovascular emergency, sepsis, etc. How to
      treat these patients appropriately and immediately is an important issue, which may change
      the disease process and prognosis, and save the life.

      Owing to the epidemic of coronavirus disease 19 (COVID-19), several changes in the
      environmental and personal protective equipment have been made in the ER when treating
      critical patients. The doctor and nurses need to wear individual protective equipment
      including Level C protective clothing, goggles, N95 mask, surgical mask, guard panel, hair
      cap, and double-layered gloves to prevent infectious droplet during tracheal intubation.
      However, the protective equipment may limit the movement and obstruct the vision and thus
      result in response delays, difficult intubation, and prolong hand-off period during
      cardiopulmonary resuscitation. On the other hand, wearing N95 mask, surgical mask and guard
      panel may impair the communication. Additionally, the medical staff may not have enough time
      to wear the protective equipment during emergency events, and therefore suffer from a higher
      risk of infection, which may consequently cause a certain level of psychological stress.

      This study aims to conduct a prospective sequential allocation clinical trial to investigate
      the success rate, patient safety, physical and psychological stress of medical staff, and the
      risk of environmental contamination of tracheal intubation and cardiopulmonary resuscitation
      between the resuscitation area and negative pressure isolation room. The results of the study
      may be used to improve the protocol and protective policy in treating critical patients
      during an epidemic.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms
time frame: 6 months
description: Comparison between the duration and number of tries needed to intubate a patient, or achieve ROSC in patients requiring cardiopulmonary resuscitation, in resuscitation area and negative pressure isolation rooms.
measure: The patient prognosis between resuscitation area and negative pressure isolation rooms
time frame: 6 months
description: Comparison between the survival rate of patients who were intubated in the resuscitation area and negative pressure isolation rooms, taking into account the duration of hospital stay, respiratory status (successful extubation, post tracheostomy, etc), and neurological state (using the Glasgow coma score, cerebral performance categories, and overall performance categories) upon discharge from the hospital.
measure: The physical and psychological stress of medical staff
time frame: 14 days
description: The medical staff involved in the intubation and/or cardiopulmonary resuscitation procedures will be asked to voluntarily fill up a survey form to determine their level of psychological stress. They will also be followed up within 14 days post exposure for covid-19 symptoms and undergo testing and quarantine if needed.
measure: The amount of environmental contamination between resuscitation area and negative pressure isolation rooms
time frame: 14 days
description: The facilities in both resuscitation area and negative pressure isolation rooms will be sampled and compared for the presence of the coronavirus after each intubation or cardiopulmonary resuscitation procedure.
arm group label: Resuscitation Area
arm group type: Experimental
description: Critical patient is assigned to the resuscitation area for treatment under medical staff on personal protective equipment; Manpower distribution during tracheal intubation: 1-2 licensed physicians, 2-3 nurses (1 for preparing intubation materials and acts as the assist, 1-2 for administering medications and documentation); Manpower distribution during cardiopulmonary resuscitation: 2 licensed physicians (1 inside resuscitation area, 1 at nurses' station), 4 nurses (2 inside resuscitation area, 2 at the sterile area)
arm group label: Negative Pressure Isolation Room
arm group type: Experimental
description: Critical patient is assigned to the negative pressure isolation room for treatment under medical staff on personal protective equipment; Manpower distribution during tracheal intubation: 1 licensed physician, 2 nurses (1 for preparing intubation materials, acts as the assist, and for administering medications; 1 for documentation at the anteroom); Manpower distribution during cardiopulmonary resuscitation: 2 licensed physicians (1 inside negative pressure isolation room, 1 at nurses' station), 5 nurses (2 inside negative pressure isolation room, 1 at the anteroom, 2 at the sterile area)
intervention type: Procedure
intervention name: Tracheal intubation and cardiopulmonary resuscitation
description: Critical patients at the emergency room who require tracheal intubation and/or cardiopulmonary resuscitation will be sequentially allocated to either the resuscitation area or negative pressure isolation room for treatment by the designated medical staff wearing personal protective equipment.
arm group label: Negative Pressure Isolation Room
arm group label: Resuscitation Area
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Min-Shan Tsai, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Critical Illness