Decision No. 30/2008/QD-BYT Issuing Guidelines for Diagnosis, Treatment, and Prevention of Influenza A (H5N1) Infection

Pursuant to …;

regarding the issuance of guidelines for diagnosis, treatment, and prevention of human infection with avian influenza A (H5N1)

THE MINISTER OF HEALTH

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, and organizational structure of the Ministry of Health;
Considering the Minutes of the Professional Council Meeting to amend and supplement the Guidelines for Diagnosis, Treatment, and Prevention of Human Infection with Avian Influenza A (H5N1) on August 2, 2008;
At the proposal of the Director of the Department of Medical Examination and Treatment under the Ministry of Health;

DECISION:

Article 1. Issuing along with this Decision the "Guidelines for Diagnosis, Treatment, and Prevention of Human Infection with Avian Influenza A (H5N1)"

Article 2. The "Guidelines for Diagnosis, Treatment, and Prevention of Human Infection with Avian Influenza A (H5N1)" shall apply to all state, semi-state, and private healthcare facilities.

Article 3. This Decision shall take effect fifteen days from the date of publication in the Official Gazette. The Decision No. 44/2006/QĐ-BYT dated December 29, 2006 issuing the "Guidelines for Diagnosis, Treatment, and Prevention of Human Infection with Avian Influenza A (H5N1)" is hereby repealed.

Article 4. The following officials are responsible for implementing this Decision: Heads of the Office of the Ministry of Health, Director of the Department of Medical Examination and Treatment under the Ministry of Health; Directors of hospitals and institutes under the Ministry of Health, Directors of health departments of provinces and centrally-administered cities, Heads of health services of relevant sectors.

GUIDANCE

DIAGNOSIS, TREATMENT AND PREVENTION OF HUMAN INFECTION WITH AVIAN INFLUENZA A (H5N1)

(Issued together with Decision No. 30/2008/QĐ-BYT dated August 19, 2008 of the Minister of Health)

Influenza virus has caused many large outbreaks worldwide with high mortality rates. There are three types of influenza viruses: A, B, and C, among which types A and B frequently cause illness in humans. These strains may change annually.

Many countries have reported cases of human infection with avian influenza type A (H5N1) with high mortality rates. In our country, there have been several patients hospitalized due to avian influenza type A subtype H5N1. The disease progresses rapidly, does not respond to conventional treatments, and has a high mortality rate.

I. DIAGNOSIS

Based on the following factors and symptoms:

1. Epidemiological factors: within two weeks in an area with outbreaks of avian influenza.  - Close contact with sick poultry (raising, selling, transporting, slaughtering, processing, consuming diseased poultry, eating raw blood, etc.)

- Close contact with suspected or confirmed cases of avian influenza A (H5N1) 

2. Clinical:

The disease presents acutely and exhibits the following symptoms:

- Fever above 38°C

- Respiratory symptoms^°C.

+ Dry cough or productive cough, chest tightness, rapid breathing, cyanosis, etc.

+ Crackles heard on auscultation.

+ Rapid progression to respiratory failure.

- Cardiovascular symptoms:

+ Tachycardia, hypotension, shock.

- Other symptoms

+ Headache, muscle pain, diarrhea.

+ Multiple organ dysfunction. 

3. Ancillary clinical:

a. Chest X-ray (mandatory):

Diffuse infiltrates on one or both sides, progressing rapidly. It is recommended to perform chest X-rays 1-2 times daily during the acute phase. b. Laboratory tests:  - Blood cell count: normal or decreased white blood cell count.

- Oxygen saturation (SpO2): below 92%

- PaO2 reduced below 85 mmHg. The ratio of PaO2/FiO2 below 300 when there is acute lung injury (ALI), below 200 when there is progressive acute respiratory distress syndrome (ARDS).

c. Microbiological diagnosis:₂- Virus:

+ Sample collection:₂ . Throat swab₂. Nasopharyngeal aspirate₂ . Bronchoalveolar lavage fluid

Properly preserved and sent promptly to a facility capable of testing to determine the cause.

+ Perform RT-PCR to identify avian influenza A/H5 virus.

- Bacteria:

+ Blood culture immediately upon admission

+ Pleural fluid and endotracheal aspirate cultures.

Diagnostic algorithm and treatment for avian influenza A (H5N1): see Appendix 1.

4. Diagnostic criteria for cases:

a) Suspected case: When all of the following criteria are met:

- Fever of 38°C or higher

- One of the following respiratory symptoms: cough, shortness of breath

- Epidemiological factor.

b) Possible case:

- Meets the criteria for a suspected case

+ Radiographic findings consistent with avian influenza progressing rapidly

+ Normal or decreased white blood cell count^°c) Confirmed case: Positive viral test for avian influenza A/H5 on a suspected or possible case.

5. Clinical staging:

Based on:

- Degree of hypoxemia on room air:

+ Prefer arterial blood gas measurement

+ Widespread use of SpO2 monitoring

- Degree of lung involvement: mandatory chest X-ray.

a) Severe:

- Shortness of breath, cyanosis

- SpO2 <50 mmHg

- Chest X-ray: diffuse bilateral infiltration

- May have multiple organ dysfunction, shock.

b) Moderate:₂

SpO2 88-92%

50-65 mmHg

- Chest X-ray: localized bilateral or unilateral infiltration.

c) Mild:₂ <88%

+ Sample collection:₂ - No shortness of breath

SpO2 >65 mmHg

- Chest X-ray: localized unilateral infiltration or indistinct lesions.

Note: The clinical course evolves very quickly, so close monitoring is necessary.

- Chest X-ray: localized bilateral or unilateral infiltration.

c) Mild:₂ 6. Triage for avian influenza A (H5N1) treatment: see Appendix 2.

+ Sample collection:₂ Triage applies during a pandemic.

II. TREATMENT

- Suspected patients must be isolated.

- Antiviral medication (oseltamivir) should be administered as early as possible.

c) Mild:₂ > 92%

+ Sample collection:₂ - Respiratory support is fundamental, maintaining SpO2

- Treatment of multiple organ dysfunction (if present).

2. Treatment of acute respiratory distress:

Management of acute respiratory distress in avian influenza A (H5N1): see Appendices 5 and 6.

a) Patient position:

Supine with head elevated at 30 degrees.

1. General principles:

b) Oxygen administration:

- Indications: When there is reduced oxygen saturation in the blood:

+ SpO2 ≤ 92% or PaO2 ≤ 65 mmHg₂ >= 92%.

+ Increased work of breathing: rapid breathing, intercostal retractions.

- Nasal cannula oxygen: 1-5 liters per minute to maintain SpO2

- Simple face mask oxygen: 6-12 liters per minute if nasal cannula oxygen cannot maintain SpO2

- Face mask with reservoir bag: sufficient flow rate to prevent collapse of the reservoir bag during inspiration, when simple face mask is ineffective. c) Continuous positive airway pressure (CPAP):^° – 45^°

- CPAP is indicated when oxygen desaturation is not improved by oxygen therapy, SpO2 <92%. If conditions permit, CPAP should be initiated immediately after failure of nasal cannula oxygen in children.

- Initiating CPAP:

+ Select appropriate mask (adult or large child) or nasal cannula (small child).₂ + Start with CPAP = 5 cmH2O.₂ + Adjust CPAP level clinically in increments of 1 cmH2O to maintain SpO2 >92%. Maximum CPAP level可达上限，以下是剩余部分的翻译：

can reach up to 10 cmH2O.

d) Mechanical ventilation:₂ > 92%.

Indications:₂ >92%.

+ CPAP or oxygen therapy does not improve oxygen desaturation (SpO2 < 90% with CPAP = 10 cmH2O).

+ Patient begins showing signs of cyanosis, rapid shallow breathing.

- Principles of mechanical ventilation:₂ Article 92%. If conditions permit, continuous positive airway pressure (CPAP) should be immediately prescribed for children when oxygen therapy via nasal prongs fails.

- Implementing CPAP:

+ Select appropriate masks (for adults and older children) or nasal prongs (for infants).

+ Begin CPAP at 5 cmH2O.₂O

+ Adjust the CPAP level clinically with increments of 1 cmH2O per adjustment to maintain SpO2 > 92%. The maximum CPAP level that can be reached is 10 cmH2O.₂Per time to maintain SpO₂ >92%. The maximum CPAP level that can be reached is 10 cmH₂O.

d) Mechanical ventilation:

- Indications:

+ CPAP or oxygen therapy does not improve hypoxemia (SpO2 < 90% with CPAP = 10 cmH2O).₂ < 90% with CPAP = 10 cmH₂O).

+ The patient begins to show signs of cyanosis and rapid shallow breathing.

- Principles of mechanical ventilation:

Objective: SpO2 >92% with FiO2₂ ≤ 0.6₂ If the above objectives are not met, an acceptable level of SpO2

- Non-invasive mechanical ventilation BiPAP (see Appendix 3):₂ > 85%.

+ Non-invasive mechanical ventilation BiPAP is indicated when the patient has respiratory failure but remains conscious, cooperative, and has good expectoration ability.

- Invasive mechanical ventilation:

+ Indicated when the patient has severe respiratory failure and does not respond to non-invasive mechanical ventilation.

+ Start with volume-controlled ventilation mode, with tidal volume (Vt) from 8-10 ml/kg, frequency 12-16 breaths/min, I/E ratio = 1/2, PEEP=5

and adjust FiO2  to achieve SpO2₂ + If it progresses to ARDS, proceed with mechanical ventilation according to the protocol for permissive hypercapnic ventilation (See Appendix 4).₂ >92%.

+ For children, pressure-controlled ventilation (PCV) may be used.

Ventilation procedure in influenza A (H5N1) pneumonia for children: see Appendix 7.

e) Pleural aspiration:

When pneumothorax occurs, pleural aspiration must be performed.

3. Other resuscitation measures

- Fluid administration: conduct fluid administration to ensure balance, maintain urine output in adults at about 1200-1500 mL/day, pay attention to avoid pulmonary edema (crackles, prominent jugular veins, weight of the patient...). If conditions permit, central venous catheter should be placed, and maintain CVP not exceeding

6.5 cmH2O. If more than 2 liters of crystalloid solution are administered without blood pressure improvement, replace with colloid solution. Where conditions permit, maintain serum albumin levels at ≥ 35g/L.  - Vasopressors: administer vasopressors early, dopamine or noradrenaline can be used in combination with dobutamine to maintain systolic blood pressure ≥ 90 mmHg.₂- Acid-base balance: ensure acid-base balance, especially during permissive hypercapnic ventilation, maintain pH ≥ 7.15.

- When the patient's condition progresses to multiple organ dysfunction syndrome, apply the resuscitation protocol for multiple organ dysfunction syndrome patients (see Appendices 8, 9).

- In places with conditions, continuous renal replacement therapy can be performed to support treatment for multiple organ dysfunction syndrome.

4. Supportive treatment

a) Corticosteroids:

- Indicated for severe cases, in the progression phase, with sepsis.

One of the following drugs can be used:

+ Methylprednisolone: 0.5-1 mg/kg/day for 7 days, intravenous injection.

+ Hydrocortisone hemisuccinate 100mg x 2 times/day x 7 days, intravenous injection. ´ + Depersolon 30mg x 2 times/day x 7 days, intravenous injection.

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+ Prednisolone 0.5-1mg/kg/day x 7 days, oral intake.

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Note to monitor blood glucose, gastrointestinal bleeding.

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b) Fever: only use paracetamol when body temperature exceeds 39°C.

c) Ensure nutritional diet and care:

- Nutrition:^°C.

+ Mild patients: feed orally.

+ Severe patients: feed milk and nutritional powder through a gastric tube.

+ If the patient cannot eat, combine with parenteral nutrition.

- Pressure sores prevention:

place the patient on water mattress, massage, change position.

- Respiratory care: help the patient cough and expectorate; chest percussion; suction sputum.

5. Antibiotic treatment: a) Antiviral drugs:

Oseltamivir (Tamiflu):

Children aged 1-13 years: use oral suspension based on body weight: <15 kg: 30 mg x 2 times/day; 16-23 kg: 45 mg x 2 times/day; 24-40 kg: 60 mg x 2 times/day for 7 days.          

Adults and children over 13 years old: 75mg ´ 2 times/day

for 7 days. In severe cases, double the dose and extend the treatment period up to 10 days. ´ Monitor liver and kidney function to adjust dosage appropriately. ´ b) Antibiotics:

- Broad-spectrum antibiotics or combinations of 2-3 antibiotics can be used if there is nosocomial infection.

- At district and commune levels, antibiotics for community-acquired pneumonia such as first and second generation cephalosporins, co-trimoxazole, azithromycin, doxycycline, gentamicin... can be used.

6. Discharge criteria:

- No fever for 7 days

- Stable blood tests, chest X-ray.

- Negative test for influenza A/H5 virus.

III. INFECTION CONTROL

Strictly implement isolation and infection control measures. When a suspected case of influenza A (H5N1) is detected, timely examination, classification, and isolation must be carried out.

2. Organizing isolation areas in hospitals:

1. Principles:

- Organize isolation areas as for other dangerous infectious diseases.

- Limit and control entry and exit from isolation areas.

- Change shoes or wear booties, wash and disinfect hands before entering and after leaving the isolation room.

3. Prevention for patients and visitors:

- Early detection and immediate isolation of suspected influenza A (H5N1) patients. Do not admit suspected patients together with other patients.

- Confirmed patients should be centralized in the Infectious Diseases Department or in departments with sufficient isolation and treatment conditions.

- All patients and suspected patients must wear surgical masks when in the ward as well as when moving outside the ward.

- Patients requiring X-rays, laboratory tests, or specialty consultations should be conducted at the bedside. If conditions do not allow, notify related departments in advance when transferring patients for imaging or testing so that healthcare workers know to prepare appropriate protective equipment. Patients must wear masks and gowns when transported within the hospital.

- Limit family members and visitors in isolation areas. Family members caring for patients or coming into contact with patients must be guided and apply infection control measures like healthcare workers.

4. Prevention for healthcare workers:

- Protective equipment includes: surgical masks, N95 masks, protective goggles, face shields, disposable gowns, gloves, caps, shoe covers or boots. Protective equipment must always be available in isolation areas.

- Each healthcare worker in isolation areas must wear full protective equipment before contacting patients and respiratory secretions. Upon leaving the isolation room, discard all protective equipment into designated waste containers and handle as infectious medical waste, and take a shower and change clothes before leaving the hospital.

Specimen for testing: Must be placed in a nylon bag or transport box according to regulations and sent to the laboratory.

- Each staff member in the isolation area must wear full personal protective equipment before contacting the patient and respiratory secretions. Upon leaving the isolation room, all protective equipment must be disposed of in designated waste containers and treated as infectious medical waste, and the staff must shower and change clothes before leaving the hospital.

- Specimen for testing: Must be placed in a plastic bag or transport container as specified and sent to the laboratory.

- Surveillance: compile a list of healthcare workers directly treating patients and those working in departments with patients. Healthcare workers showing signs of suspected infection must be examined, tested, and monitored like suspected severe influenza patients.

- Immediately report suspected and confirmed cases to the local Preventive Health Center and the Ministry of Health.

5. Handling medical equipment, textiles, and patient-use items:

- Medical equipment: reusable equipment must be disinfected immediately in the isolation area, then transferred to the washing room for cleaning and sterilization according to regulations.

- Patient-use items: must be washed and sanitized with soap and disinfectants daily and each time they become soiled. Each patient has their own hygiene and nutrition service items.

- Textiles: Apply handling and processing methods as for contaminated textiles. Collect textiles in yellow plastic bags before transporting them to the laundry. Do not soak textiles in the isolation area. Wash textiles in disinfectant solutions. If hand washing is necessary, textiles must be soaked in disinfectant prior to washing.

6. Environmental and hospital waste management:

Follow procedures for environmental and waste management as specified for contaminated cases.

7. Patient transportation:

- Principles:

+ Minimize patient transportation.

+ Transport patients only when their condition exceeds the treatment capacity of the facility.

+ Ensure adequate resuscitation equipment such as oxygen masks, oxygen tanks, CPAP machines, and Ambu bags with PEEP valves during transportation.

+ Ensure safety for both patients and transport personnel (drivers, healthcare workers, family members, etc.) following infection prevention guidelines.

- Transportation staff must wear full personal protective equipment: surgical masks, disposable gowns, face shields, gloves, and hats.

- Decontaminate ambulances after each patient transport using standard disinfectants.

- Wash hands and sanitize hands upon completion of transportation.

8. Handling deceased patients:

- Deceased patients must be embalmed on-site according to disease control regulations, using disinfectants such as chloramine B.

- Transport deceased patients to burial or cremation sites using dedicated vehicles and ensure compliance with infection control regulations.

- Cremate or bury deceased patients within 24 hours after death, preferably through cremation.

9. General preventive measures:

- Personal hygiene, nasal irrigation, and gargling with antiseptic medications.

10. Antiviral prophylaxis:

Target group: Healthcare workers and those directly caring for patients infected with Influenza A/H5 without proper protective gear.

Dosage: oseltamivir 75 mg, one tablet per day for seven days.

11. Specific vaccines:

Research is currently underway for specific vaccines against the Influenza A H5N1 virus.H5N1./.