Clinical trial NCT04479332: The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)
Official title: The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Infection
Critical Illness
Keywords: Coronavirus disease 19 (COVID-19)
Critical care
Endotracheal intubation
Cardiopulmonary resuscitation
Stress
Environment contamination
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 198
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms
timeFrame: 6 months
measure: The patient prognosis between resuscitation area and negative pressure isolation rooms
timeFrame: 6 months
measure: The physical and psychological stress of medical staff
timeFrame: 14 days
measure: The amount of environmental contamination between resuscitation area and negative pressure isolation rooms
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Min-Shan Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin CH, Lin HY, Wu SN, Tseng WP, Chen WT, Tien YT, Wu CY, Huang CH, Tsai MS. Using a telemedicine-assisted airway model to improve the communication and teamwork of tracheal intubation during the coronavirus disease 2019 pandemic. J Telemed Telecare. 2024 Aug;30(7):1140-1148. doi: 10.1177/1357633X221124175. Epub 2022 Sep 6.