Corona Virus InfectionNCT04479332
The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)
A study testing Tracheal intubation and cardiopulmonary resuscitation in people with Corona Virus Infection and Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Corona Virus Infection, Critical Illness
- What is being tested?
- Tracheal intubation and cardiopulmonary resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Aug 2020to 23 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- showing respiratory distress
- require airway protection
- EOC notified of an out-of-hospital cardiac arrest
- staff who attended index intubation or resuscitation are encouraged to answer the survey form
Who cannot join
- 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
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Corona Virus Infection, Critical Illness
- Being tested
- Tracheal intubation and cardiopulmonary resuscitation
- Keywords
- Coronavirus disease 19 (COVID-19), Critical care, Endotracheal intubation, Cardiopulmonary resuscitation, Stress, Environment contamination
- Medical subject headings
- Coronavirus Infections, Critical Illness, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubation and cardiopulmonary resuscitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Tracheal intubation and cardiopulmonary resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start19 Aug 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min-Shan Tsai, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479332
- Sponsor's protocol ID
- 202005094RIND
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36066025
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)
- ClinicalTrials.gov ID
- NCT04479332
- Acronym / sponsor ID
- 202005094RIND
- Conditions
- Corona Virus Infection, Critical Illness
- Keywords
- Coronavirus disease 19 (COVID-19), Critical care, Endotracheal intubation, Cardiopulmonary resuscitation, Stress, Environment contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resuscitation Area | Experimental | Procedure: Tracheal intubation and cardiopulmonary resuscitationCritical 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) |
| Negative Pressure Isolation Room | Experimental | Procedure: Tracheal intubation and cardiopulmonary resuscitationCritical 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- showing respiratory distress
- require airway protection
- EOC notified of an out-of-hospital cardiac arrest
- staff who attended index intubation or resuscitation are encouraged to answer the survey form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheal intubation and cardiopulmonary resuscitationCritical 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. | Procedure or surgery | Negative Pressure Isolation Room, Resuscitation Area |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 36066025Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Shan Tsai, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal intubation and cardiopulmonary resuscitation in people with Corona Virus Infection and Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.