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

NCT04479332 | Completed

• 1 other identifier: 202005094RIND
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection; Critical Illness

Keywords

Coronavirus disease 19 (COVID-19); Critical care; Endotracheal intubation; Cardiopulmonary resuscitation; Stress; Environment contamination

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Resuscitation Area

EXPERIMENTAL

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

Negative Pressure Isolation Room

EXPERIMENTAL

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

Interventions

Tracheal intubation and cardiopulmonary resuscitation PROCEDURE

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.

Negative Pressure Isolation Room; Resuscitation Area

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• staff who attended index intubation or resuscitation are encouraged to answer the survey form
• none

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36066025 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Critical Illness; COVID-19

Interventions

Intubation, Intratracheal; Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Resuscitation; Emergency Treatment

Study Officials

• Min-Shan Tsai, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: August 19, 2020
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: January 28, 2022

Record last verified: 2020-07

Locations

TW (1)