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The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04479332
Recruitment Status : Not yet recruiting
First Posted : July 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Critical Illness Procedure: Tracheal intubation and cardiopulmonary resuscitation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resuscitation Area
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)
Procedure: Tracheal intubation and cardiopulmonary resuscitation
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.

Experimental: Negative Pressure Isolation Room
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)
Procedure: Tracheal intubation and cardiopulmonary resuscitation
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.




Primary Outcome Measures :
  1. The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms [ Time Frame: 6 months ]
    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.

  2. The patient prognosis between resuscitation area and negative pressure isolation rooms [ Time Frame: 6 months ]
    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.

  3. The physical and psychological stress of medical staff [ Time Frame: 14 days ]
    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.

  4. The amount of environmental contamination between resuscitation area and negative pressure isolation rooms [ Time Frame: 14 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Critical Care Patients:

  • showing respiratory distress
  • require airway protection
  • EOC notified of an out-of-hospital cardiac arrest

Exclusion Criteria for Critical Care Patients:

  • age less than 20 years old
  • pregnant
  • in-hospital cardiac arrest in patients prior to intubation
  • confirmed cases of covid-19 prior to intubation
  • patient or patient's family refuses the procedure

Inclusion Criteria for Medical Staff:

  • staff who attended index intubation or resuscitation are encouraged to answer the survey form

Exclusion Criteria for Medical Staff:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479332


Contacts
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Contact: Min-Shan Tsai, MD 0972651959 mshanmshan@gmail.com

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Min-Shan Tsai, MD National Taiwan University Medical College and Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04479332    
Other Study ID Numbers: 202005094RIND
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Coronavirus disease 19 (COVID-19)
Critical care
Endotracheal intubation
Cardiopulmonary resuscitation
Stress
Environment contamination
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Critical Illness
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases