A Multicentered Study on Efficiency of Noninvasive Ventilation Procedures
Condition: Noninvasive Positive Pressure Ventilation; High Flow Nasal Cannula; Failure, Respiratory
MeSH terms: Respiratory Insufficiency
Study type: Observational [Patient Registry]

Summary: 
      Noninvasive ventilation (NIV) is an alternative form of ventilatory support in critical care
      encompassing different modes of ventilation such as continuous positive airway pressure
      (CPAP), bilevel positive airway pressure (BiPAP) and high flow nasal cannula ventilation.
      Although numerous studies on adults exit in literature, the aspects of this ventilatory
      support is limited in pediatric age groups. Early recognition of respiratory failure and
      initiation of NIV in a pediatric patient would positively affect prognosis by avoiding
      certain complications of endotracheal intubation and mechanical ventilation and adds certain
      advantages. Decreasing re-intubation rates for the ones who are extubated but necessitating
      further oxygen support is another advantage of NIV. Although numerous studies on adults exit
      in literature, the aspects of this ventilatory support is limited in pediatric age groups.
      Besides, success as well as failure and complication rates in pediatric age groups vary
      extensively. This multi-centered, prospective cohort study is planned to observe the
      epidemiologic perspectives of study group within underlying problems, success rates between
      different age groups, complication and re-intubation rates and finally its' effect on
      prognosis and long term survival in a year period. Hence we believe results of this study
      would allow us to improve our knowledge on using this technique, applying different modes and
      parameters appropriately and design criteria to guide clinician in deciding which group of
      patients would benefit from NIV techniques.
    

Detailed description: 
      Total of 9 pediatric critical care centers all across the country will collaborate at this
      study:

        1. Akdeniz University Faculty of Medicine, Pediatric Critical Care Division

        2. Cukurova University Faculty of Medicine, Pediatric Critical Care Division

        3. Ege University Faculty of Medicine, Pediatric Critical Care Division

        4. Ankara University Faculty of Medicine, Pediatric Critical Care Division

        5. Ondokuz Mayis University Faculty of Medicine, Pediatric Critical Care Division

        6. Erciyes University Faculty of Medicine, Pediatric Critical Care Division

        7. Koc University Faculty of Medicine, Pediatric Critical Care Division

        8. Dokuz Eylül University Faculty of Medicine, Pediatric Critical Care Division

        9. Izmir Katip Celebi University Faculty of Medicine, Pediatric Critical Care Division
           Since nature of this study is an observational cohort, all noninvasively ventilated
           children from one month to eighteen years will be enrolled in this study. A three-page
           questionnaire is designed to collect data. The first page includes information on
           epidemiological data, underlying disease in terms of both acute and chronicle problems
           resulting in respiratory problems; the second page includes a multi-colon table to
           record vital signs (heart and respiratory rate, systemic and diastolic blood pressure),
           PRISM-III and Pediatric logistic organ dysfunction (PELOD) scores, Glasgow coma scale,
           blood gas values, ventilation parameters, necessity of sedation (if so, drugs used for
           sedation) and finally comfort pain scores. Data will be collected immediately prior to
           commencing NIV, the first, second and sixth hours; if NIV support continues over 24
           hours, then daily data will be obtained up to five days. Last questionnaire page
           consists of data for clinical outcome, reason of NIV failure, necessity of re-intubation
           and if so timing of re-intubation.

      Primary outcome of this study is to observe success rates in decreasing necessity of
      mechanical ventilation or re-intubation. Successfully managed children will also be evaluated
      for age groups, underlying disease as well as modes of delivery and ventilation parameters to
      define thresholds on decision of NIV success or failure. Secondary outcome is to evaluate the
      NIV failure in terms of pediatric age groups, underlying disease, rates of NIV-related
      complications. If a respiratory failure occurs, modes of delivery and ventilation parameters,
      usage of different masks, timing of failure decision according to patients' clinical data
      will be explored from collected data.

      Each center will fill in the questionnaire according to patient data and every two months
      period data will be collected from collaborators. After one year period, statistical
      evaluation will be investigated by the principle investigators.

      Below participants may observe the questionnaire form:

      Form - I

        1. Age (months):

        2. Sex:

        3. Weight (kg):

        4. PRISM - III score

        5. Which one of the following describes the underlying disease? i. What is the
           acutely-developed illness that required noninvasive ventilation? (Can be marked more
           than one option)

             1. Heart failure

             2. Pneumonia

             3. Bronchiolitis /Asthma

             4. Acute respiratory distress syndrome (ARDS)

             5. Sepsis

             6. Laryngeal stridor after extubation (or respiratory distress)

             7. Other (please describe) :

           ii. What is the chronic underlying disease (Primary disease which occurred previously)
           (can be marked more than one option)

             1. Neuromotor disease

             2. Metabolic disease

             3. Malignancy

             4. Congenital cardiac disease

             5. Chronic pulmonary disease

             6. Immune deficiency

             7. Other (please specify)

             8. No chronic underlying disease

        6. What is the type of respiratory insufficiency?

             1. Hypoxemic (Type I)

             2. Hypercapnic (Type II)

        7. Was the patient intubated before noninvasive ventilation?

             1. Yes

             2. No

        8. If participant's answer is YES to previous question, please describe the length of
           intubation period (hours):

        9. Which one of the following describes NIV device?

             1. Specific noninvasive ventilation device

             2. Conventional mechanical ventilator with the noninvasive mode

             3. High flow nasal cannula

             4. BIPAP device (without oxygen blender)

             5. Other:

       10. Which one of the mask types did participant apply in the patient?

             1. Nasal mask

             2. Oronasal mask

             3. Full face mask

             4. Nasal prong (cannula)

             5. Endotracheal tube

             6. Other (please specify):

      Form - II: Variables attached below will be recorded at initial, first, second, sixth, 24th,
      48th, 72th, 96th, 120th hours.

        -  Respiratory rate

        -  Heart rate

        -  Systolic tension

        -  Mean tension

        -  Diastolic tension

        -  PRISM - III score

        -  PELOD score

        -  Glasgow coma score

        -  Blood gas (arterial/ venous/ capillary)

        -  Partial arterial oxygen concentration (PaO2) / Fraction of Inspired oxygen (FiO2)

        -  Oxygen saturation (SpO2) / Fraction of Inspired oxygen ( FiO2)

        -  Partial arterial carbon dioxide concentration (PaCO2)

        -  Power of Hydrogen (pH)

        -  Device Mode

        -  Inspiratory positive airway pressure (IPAP) value

        -  Expiratory positive airway pressure (EPAP) value

        -  Fraction of inspired oxygen (FiO2) value

        -  Inspiratory time (IT)

        -  Rise time value

        -  Tidal volume

        -  Leakage (%)

        -  Mandatory rate

        -  High flow rate

        -  Sedo-analgesia drugs and dosage

        -  Comfort score

      Form - III

        1. Please select your observation on NIV success.

             1. Patient had to be re-intubated after 48 hours of NIV.

             2. Patient was successfully withdrawn from NIV in 48 hours.

             3. Patient received noninvasive ventilation for ……………………days.

        2. If participant's answer is 'A' to the previous question, please specify the reason of
           re-intubation below (can be marked more than once)

             1. Patient - ventilator asynchrony

             2. Face - mask mismatch

             3. Significant leakage percentage

             4. Progress to respiratory failure (can be marked more than once) (i) SpO2/FiO2<193 in
                0-1 hour (ii) FiO2 necessity > %80 (iii) Blood gas power of hydrogen (pH) <7.25 in
                two hours (iv) Failure to achieve 10% expected decrease in respiratory rate at
                second and sixth hours (v) Increase in clinically observed respiratory effort (vi)
                Progression to severe ARDS (Oxygenation index > 8)

             5. Neurologically deteriorating patient (Glasgow coma score < 8 or deterioration over
                three units)

             6. Risk of aspiration or bulbar dysfunction (loss of swallowing)

             7. Hemodynamic instability

             8. Arrythmia

             9. Pneumothorax

            10. Other (please specify):

        3. If participant observes a complication in the patient, please specify below (can be
           marked more than once).

             1. Loss of skin intact

             2. Pneumothorax

             3. Puking and aspiration pneumonia

             4. Hemodynamic instability

             5. Other (please specify): ……………….................

             6. No complication was observed.

        4. Please specify the length of noninvasive ventilation ………………………….. (hours)

        5. If patient received NIV breaks in a day, please write down the length of ventilation
           hours per day.

           Day 1:……………………………… Day 2: …………………………………...

        6. What is clinical outcome of the patient after noninvasive ventilation support?

             1. Respiratory failure diminished and patient was discharged from Pediatric intensive
                care unit (PICU) after ……………. (days / hours) .

             2. Patient was discharged form PICU with home- style noninvasive device after ……………
                days/hours)

             3. Patient necessitated tracheostomy.

             4. Patient died of respiratory failure after ………………. days/hours.

        7. What is the length of hospital discharge? (please specify): …………………….
    

Intervention name(s): noninvasive ventilation respiratory support
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all noninvasively ventilated children from one month to eighteen years will be enrolled in
        this study
      
Keywords: Noninvasive Positive Pressure Ventilation; Nasal high flow; Respiratory Failure; Childhood