Quyết định 125/QĐ-BYT 2020 chẩn đoán và điều trị bệnh viêm phổi cấp do virus Corona

DECISION

Promulgating the Guidance on the diagnosis and treatment of the acute pneumonia caused by new a strain of Coronavirus (nCoV)

THE MINISTER OF HEALTH

Pursuant to the Law on Medical Examination and Treatment 2009;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 prescribing the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the request of the Director of the Department of Medical Examination and Treatment Management – Ministry of Health,

DECIDES:

Article 1.Issuing together with this Decision “The Guidance on diagnosis and treatment of the acute pneumonia caused by a new strain of Coronavirus (nCoV)”.

Article 2.The Guidance on diagnosis and treatment of the acute pneumonia caused by a new strain of Coronavirus (nCoV) shall be applicable to all public and private medical examination and treatment establishments nationwide.

Article 3.This Decision shall take effect on the date of signing and issuance.

Article 4.The Chief of Ministry office, the Director of the Department of the Medical examination and treatment management – Ministry of Health; Directors of General departments, Departments under the Ministry of Health; Directors of Hospitals and Institutes under the Ministry of Health; Directors of municipal and provincial Departments of Health; Heads in charge of Healthcare of sectors shall be responsible for implementing this Decision.

For the Minister

The Deputy Minister

Nguyen Truong Son

GUIDANCE

On the diagnosis and treatment of acute pneumonia caused by a new strain of Coronavirus (nCoV)

(Issued together with the Decision No. 125/QD-BYT dated January 16, 2020 of the Minister of Health)

Coronaviruses are a large family of viruses that can cause illnesses ranging from common cold to more severe diseases threatening human lives, including Severe Acute Respiratory Syndrome (SARS-CoV) in 2002, and the Middle East respiratory syndrome (MERS-CoV) in 2012. However, since December 2019, a new strain of Coronavirus causing pneumonia in Wu Han (China) has been detected and likely to be fast-spreading.

People contracting shall have the following symptoms: coughing, breathing difficulties. In more severe cases, it can lead to acute respiratory failure and even death, especially in patients with chronic illnesses or immunodeficiency.

Now, there is no specific treatment and vaccine for this disease yet.

I. DIAGNOSIS OF INFECTIONS CAUSED BY A NEW STRAIN OF CORONAVIRUS

1. Suspected case:

Suspected cases shall include the following cases:

1.1. Having fever and pneumonia, or interstitial pneumonia, or acute respiratory distress syndrome (ARDS), based on clinical findings or X-ray images showing different levels of lung injury which infection or other causes cannot explain. This includes all cases with clinical indication to test community-acquired pneumonia.

And:Living or travelling to areaswhere there are diseases caused by the new strain of Coronaviruses within 14 days prior to the symptom onset.

- Being in contact (within the incubation period of 14 days) with patients who contract unexplained fever and severe acute respiratory infection arising within 14 days after travelling to nCoV-affected areas.

1.2. Having fever and symptoms of lung diseases (cough, breathing difficulties, etc.)

And:

Being present at a health care facility of areas where there are confirmed cases of 2019-nCoV infection.

Or

- Being in direct contact with infected domestic animals or wild animals at affected areas within 14 days.

1.3. Having fever or symptoms of respiratory diseases arising within 14 days after having contact with a confirmed or probable cases of 2019 nCoV infection.

2. Probable case:

There shall be cases probable of 2019 nCoV infection if there are clinical and epidemiological evidences as follows:

Clinical evidence:

People in direct contact with cases confirmed by laboratory testing, including people taking care of the patients: medical staff, family members; people living with the patients or people visiting the patients during the time of symptom presentation.

Epidemiological evidence

Patients having epidemiological evidence, X-ray filming, pathogen test of lung parenchyma diseases (for example pneumonia or ARDS) matching the above-stated definition of the case,

And

- Not having any laboratory confirmation due to failure in collecting samples, or failure to conduct laboratory tests to diagnose the cause of respiratory infection

- Failing to explain the clinical presentation by infections or other causes.

3. Confirmed case

Confirmed case means cases with the above-stated clinical presentation and which have been tested positive with nCoV by the Real time RT-CT laboratory test.

4.Differential diagnosis

There shall be differential diagnosis to distinguish Pneumonia caused by nCoV from:

- Severe influenza (A/H1N1 influenza or H5N1 bird influenza, etc.)

- SARS-CoV and MER-CoV

- Atypical pneumonia by other causes: Syncytial Respiratory Virus (SRV), adenovirus, and mycoplasma, etc.

5. Para-clinical testing

- The technique used to detect nCoV is the Real time RT-PCR, using such specimens as respiratory specimens, sputum, and endotracheal tube aspirate collected by swabs and stored in proper environment. Note: For the first suspected case of the new strain of Coronavirus, specimens must be stored and transported to a testing lab approved by the Ministry of Health.

- The collection, storing and transportation of specimens must be conducted in accordance with regulations of Appendix 1.

- Regular laboratory tests must be conducted in full to diagnose, prognose and monitor patients.

6. Report:

Newly confirmed or probable nCoV cases must be reported to the Department of Preventive Medicine (Ministry of Health) or the Center for Epidemic control at their localities.

II. TREATMENT

1. Treatment principles

- Suspected or probable cases must be isolated in an appropriate health facility, their specimens must be collected in a proper way to conduct specificity test for diagnosis and disease detection.

- All cases must be hospitalized for monitoring and complete quarantine.

- Up to now, there have yet to be any vaccines and medicines for the treatment of 2019 nCoV, therefore, the focus is on treating the symptoms, timely detection and treatment of the acute respiratory syndrome, chronic kidney disease, and chronic disease in other organs (if any).

2. Treatment of acute respiratory syndrome

2.1. Uncomplicated level:

- Keep patient in semi-recumbent position (head of bed elevation 30-45º)

- Oxygen therapy: when SpO2 ≤ 92% or PaO2 ≤ 65mmHg or in case of breathing difficulties (fast breathing, shortness of breath, chest recession).

- Oxygen therapy through nasal cannula: Initiate at 1-5L/min to reach target SpO2 ≥92%.

- Oxygen therapy through simple face mask: Initiate at 6-12L/min in case where Oxygen therapy through nasal cannula cannot reach target SpO2 ≥ 92%.

- Oxygen therapy through mask with reservoir bag: Store an adequate amount of oxygen so that the reservoir bag cannot shrink when inhaling, used in case where the simple facemask cannot function effectively.

2.2. Moderate level

- Apply CPAP Oxygen therapy or High flow nasal cannula oxygen therapy (if any): in case where oxygen therapy fails to alleviate hypoxemia and SpO2 < 92%. If the condition allows, children should be on CPAP therapy immediately after the nasal cannula oxygen therapy fails to function.

+ Target: SpO2 ≥ 92%. With FiO2 equal to or lower than 0.6.

+ If the above target cannot fulfill, the target SpO2 > 85% is acceptable.

- Use BiPAP therapy (Bi-level Positive Airway Pressure): when a patient with severe respiratory syndrome is still conscious, can react properly and can cough out.

2.3. Severe level

Respiratory Care

Implement invasive ventilation:

+ For patients with severe acute respiratory distress syndrome and cannot adapt to non-invasive pressure ventilation.

+ Begin by implementing the volume control ventilation, with the low tidal volume from 6 to 8 ml/g, the frequency of 12 – 16 times/minute, I/E = 1/2, PEEP = 5, and adjust FiO2 to reach SpO2 > 92%.

+ In case where a patient develops ARDS, mechanic ventilation can be used according to the increased ventilation regimen approved.

+ For children, patients of such kind can undergo pressure control ventilation. Depending on the situation of the patient, the ventilator shall be adjusted.

- Extra-Corporeal Membrane Oxygenation (ECMO):

+ ECMO can be considered for use in case where ARDS patients cannot adapt to the above-stated optimal treatments.

+ For the fact that ECMO can only be conducted in some centrally-run hospitals, hospitals at lower level should make prompt decision to send patients who are prescribed to undergo ECMO to central hospitals and should strictly follow the procedure of transporting patients as specified by the Ministry of Health.

Support for other organs’ function:

Hemodynamic stabilization: - Ensure the circulation volume, cardiac and vasopressor medicines if needed.

Renal function support:

- Ensure the fluid balance, stable hemodynamics, and diuretics medicines.

- Dialysis (intermittent or continuous) or peritoneal dialysis when prescribed.

Support for other organs’ function:depending on specific cases.

3. Adjuvant therapy:

- Use cough relief medicines if a patient has persistent cough: use common nasal drops.

- For fever relief: If a patient’s temperature is 38.5or higher: use paracetamol with the dosage of 10-15mg/kg in children and at most 2g/day in adults.

- Adjust disorders of water balance, electrolyte, and acid base balance.

- Ensure nutrition, control glycemic index.

- Patients with bronchial superinfection should be treated with broad-spectrum antibiotics which can take effect on bacteria causing infection in hospitals.

- For severe cases,Intravenous immune gammaglobulin ("IVIG") should be considered for use.

- Background treatment (if any)

4. Hospital discharge standards

Patients shall be discharged from hospitals if they are able to satisfy the following standards:

- Their patients ends in at least 03 days.

- They are in good conditions: pulse, blood pressure, breathing, blood tests return to normal state; X-ray filming of lungs has improved.

- Renal functions have returned to normal condition.

5. After hospital discharge

Patients must self-monitor their body temperatures 12 hours/time, if their temperature is above 38C in 2 consecutive times of measurement, or if there are any extraordinary indications, these patients must undergo medical re-examination at the hospital they are previously treated.

III. PREVENTION OF NOVEL CORONAVIRUS INFECTION

1. Prevention of infection in the community

- Wear face masks and visit a medical examination establishment right after there are any respiratory symptoms.

- Personal hygiene measures:

+ Clean handwash: Regularly wash hands with soaps and water or with an alcohol-based hand rub, especially after sneezing, coughing or touching nose.

+ Cover nose and mouth when sneezing and coughing; throw used tissues for cleaning mouth and nose into a separate trash bin.

+ Ensure adequate diets.

+ Quit smoking

- Environmental hygiene:

+ Ensure good ventilation in working and living places.

+ Avoid contact and gather in crowded places.

+ Avoid direct contract with domestic and wild animals.

+ Conduct adequate vaccination.

2.Prevention of infection in hospitals

Strictly conduct separation in medical examination, isolation and treatments of patients, infection control measures, and measures to prevent infection to health workers, caregivers of nCoV-infected patients and other patients at the medical treatment in accordance with guidance provided by the Ministry of Health.

2.1. Organization of quarantine areas:

- High-risk areas: The place for treatment and care of patients who are suspected or confirmed to contract the new strain of Coronavirus. Areas for treatment of such patients must be signaled by a red notice of “Area of special quarantine” and a detailed written guidance at the entrance and must be guarded by people on duty.

- Risk areas: The place where there are highly likely that new nCoV-infected patients come to conduct initial medical examination and treatment ( for example Department of Pulmonary, Department of Emergency, Department of Medical treatment, etc.). This area must be signal by an instruction board at the entrance and have yellow symbol.

- Patients must be place in quarantine and under treatment at a healthcare facility to minimize the risk of complications and death. Patients shall be in quarantine until there are no longer any clinical symptoms.

- Patients undergoing no breathing difficulties must wear face masks properly when being in contact with other people to minimize the risk of the disease infection.

2.2. Infection prevention for patients and visitors

- Immediately place any suspected patients in quarantine, separate confirmed cases of nCoV from suspected cases. All patients must wear face masks. Such works as X-ray filming, testing, specialized examination, etc. should be conducted right at the patient’s bed, in case where the patient has to be transported, there must be adequate means of protective gears. Patients should expectorate into a single-use tissue and discharge immediately after use into a medical trash bin.

- Conduct personal hygiene, regularly wash hands with soaps; use antiseptic medicines for nose and throat such as: mouth gargle with antiseptic water, or other antiseptic liquids for nose and throat.

- Avoid gathering in crowds to prevent infection to other people.

- In time of the epidemic, direct contact with infected patients and other people should be minimized. Family relatives and visitors should be banned from entering the quarantine area.

- People in close contact with infected people must be listed and be under healthcare monitoring within 14 days after the last time of being in contact. These people must be provided with consultation on the disease symptoms and preventive measures to self-prevent, self-monitor, and detect early any symptoms of the acute respiratory infection. In case where there are symptoms of fever, coughing, breathing difficulties, such people must immediately report to the nearest healthcare facility for timely diagnosis and treatment.

- Ensure good ventilation in patient rooms.

2.3.Infection prevention for medical staff

- Medical staff must wear surgical facemasks, medical glasses, face-covering masks, single-use paper coveralls, gloves, medical caps, shoe covers or boots. On conducting medical procedures or giving direct care to patients, medical staff should use N95 face masks. Patient’s collected specimens for testing must be place in nylon seals or in shipping containers. Medical staff must apply handwash with soaps or disinfectant liquids after touching patient’s respiratory fluids, dirty instruments, after taking care of patients, after putting off gloves, facemasks and after leaving patient rooms, quarantine area. Medical staff in direct contact with patients in the quarantine area must take shower, and change clothes before leaving their hospital.

- Hospitals must compile a list of medical staff working at departments where there are new cases of contracting the new strain of Coronavirus. These medical staff have to self-monitor their temperature daily, if there are any signs of contracting nCoV, they shall be under medical examination, testing and healthcare monitoring.

2.4. Treatment of medical equipment, textiles and daily necessities of patients

This treatment shall be conducted in accordance with the infection control procedure of the Ministry of Health.

2.5. Environmental hygiene and treatment of medical waste

All surfaces, tables and chairs in patient rooms and the quarantine area must be wiped at least 02 times/day with antiseptic chemicals. Cleaning staff must use protective equipment like medical staff. All solid waste in the quarantine area must be collected for incineration under regulations of the Ministry of Health.

2.6. Patient transport

Limit the transportation of patients, except for severe cases going beyond the treatment capacity of a healthcare facility. Transportation personnel must bring adequate protective equipment. After each time of transportation, the ambulance car must be cleaned and disinfected.

2.7. Handlings of deceased patients

The deceased patients must be shrouded in place, disinfected with Chrolamin B and Pormalin. The bodies shall be transported to the burial or cremation place by a specialized vehicle. Such bodies shall be buried or cremated within 24 hours. It is recommended that these bodies be cremated./.

For the Minister

The Deputy Minister

Nguyen Truong Son

APPENDIX 1
COLLECTION, STORAGE AND TRANSPORT OF SPECIMENS

1. Specimens

Specimens suspected to be infected with nCoV must be collected by medical workers well-equipped with knowledge on biosafety. The collection of specimens shall consist of at least 02 specimens, including 01 respiratory specimen and 01 blood sample from the following types:

- Upper respiratory tract specimens:

+ Mixed nasopharyngeal fluid;

+ Throat rinse.

- Lower respiratory tract specimens:

+ Sputum;

+ Alveolar fluid, endotracheal fluid, pleural fluid, etc.;

+ Tissues of lungs, bronchi, alveoli.

+ Blood sample (3-5 ml of venous blood with/without EDTA)

+Blood sample collected in acute stage;

+ Blood sample collected in recovered stage (14-21 days after the onset of illness).

2. Time for collecting specimens

3. Methods of collecting specimens

3.1. Preparing instruments

- Soft and hard sterile cotton swabs.

- Tongue depressors.

- 15ml conical centrifuge tubes, containing 2-3ml of transport medium.

- Plastic vials (Falcon 50ml tubes) or nylon bag for packaging specimens.

- Antiseptic bandages and gauzes.

- Antiseptic alcohol, writing pen, etc.

- Protective clothing

- Eye protection goggles.

- Gloves.

- N95 respirators.

- Sterile 10ml syringes.

- Sterile test tubes (with/without anticoagulant).

- Quick release tourniquet, cottons, alcohol, etc.

- Cold boxes.

3.2. Process

3.2.1. Wearing protective clothing

 3.2.2. Techniques for specimen collection

a. Nasal and throat fluids (using 02 separate swabs for 02 types of specimens)

- Soak the tip of the swab into the throat fluid in the oropharynx, then squeeze and swirl the swab at the tonsils and the back of the throat to collect infected cells.

- Ask the patient to turn his/her face up at about 45 degrees, then put the swab along the nasal floor into the nasal cavity and soak it in the nasal fluid, then squeeze and swirl the swab at the nasal wall and gently pull it out.

- After being used to swab the throat and nose, the 02 swabs containing the specimens shall be stored in 01 tube containing 3 ml of transport medium (the tips of the swabs must be submerged in the transport medium).

b. Throat rinse

Patients are requested to gargle with 10 ml of washing solution (physiological saline). The rinse then shall be collected and stored in a beaker or a petri dish and diluted at a 1-to-2 ratio with a virus storage medium.

c. Endotracheal fluid

The patient shall be intubated and on mechanical ventilation. Placing 01 suction catheter along the trachea and using a syringe to suck the endotracheal fluid out through the catheter. Storing the endotracheal fluid in a tube containing virus storage medium.

d. Blood sampling

Use a sterile needle and syringe to get 3-5ml of venous blood, then store the blood in a tube (with EDTA for whole blood, and without EDTA for aliquoting blood) at 4oC within 24 hours.

Notes:

- Write the name, age, address of the patient, type of specimens, date of sampling on the specimen-containing tubes 

- Specimens collected from the lower respiratory tract (endotracheal, alveolar, pleural fluids) shall be coordinated with the clinician while conducting specimen collection.

3.2.3. Sterilizing the instruments and disinfecting the sampling area

- All protective clothes, along with other dirty instruments, shall be put into a specialized plastic bag designed for containing medical waste which is capable of withstanding high temperatures (On-duty medical workers must use new gloves and facemasks).

- Such bags must be tied and dried at 120oC in 30 minutes before discarded together with other medical waste or burned in waste incinerators of district-level hospitals.

- The on-duty medical workers must wash their hands with soap and disinfect all sampling instruments and areas, and the cold boxes used to transport specimens to the laboratory with chloramine 0.1%.

4. Preserving, packaging and transporting specimens to the laboratory

4.1. Preservation

After being collected, specimens shall be sent to the laboratory in the shortest time:

- Samples shall be stored at 2-8°C, and transferred to the laboratory as soon as possible, within less than 48 hours after being collected.

- Specimens shall be stored at -70°C in case the specimens are expected to be delivered to the laboratory in more than 48 hours after being collected.

- Specimens shall not be stored in the freezer compartment of the refrigerator or at -20°C.

- Specimens of serum/plasma can be stored at 4°c within 05 days.

4.2. Packaging the specimens

Transported specimens must be carefully packaged under 03 protective layers in line with the World Health Organization s regulations.

- Tightly twist the screw cap of each specimen tube and cover it with paraffin paper (if any), then wrap each tube with absorbent paper.

- Put the tubes into a shipping bag (or a container with a tight lid).

- Wrap such bag with absorbent paper or absorbent cotton wool with disinfectants (chloramine B...), place the specimen package in a second nylon bag, and then seal it tightly.

- The specimen statements shall be packaged together in the last outer nylon bag which then is sealed tightly and contained in a cold box stamped with warning signs of the World Health Organization (“Biological Specimen” sign, “Do not put upside down” sign) during the delivery.

4.3. Transportation of samples to the laboratory

- Specimen receivers:

+ Central Laboratory of Hygiene and Epidemiology shall receive specimens from Northern provinces.

+ Laboratory of Pasteur Institute in Ho Chi Minh City shall receive specimens from provinces in the South and the Central Highlands.

+ Laboratory of Pasteur Institute in Nha Trang shall receive specimens from Central provinces.

Based on the development of the epidemic nCoV and the testing capacity of the laboratories, the Ministry of Health shall consider appointing additional necessary specimen receivers.

- Notify the laboratory the date and the estimated time the specimens will arrive at the laboratory.

- Specimens shall be delivered to the laboratory by road or air as soon as possible.

- Absolutely avoid broking the specimen tubes during the delivery.

- Specimens shall be stored at 4°C when being transported to the laboratory, avoiding multiple freezing-thawing processes spoiling the specimens.