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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479332
• Other study ID #: 202005094RIND
• Status: Completed
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: February 23, 2021

Study information

• Verified date: July 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms	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.	6 months
Primary	The patient prognosis between resuscitation area and negative pressure isolation rooms	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.	6 months
Primary	The physical and psychological stress of medical staff	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.	14 days
Primary	The amount of environmental contamination between resuscitation area and negative pressure isolation rooms	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.	14 days