Airway Pressure and Lumen Changes During NIV With Flexible Bronchoscopy
Condition: Airway Disease
Study type: Interventional

Summary: 
      Introduction: The non-invasive ventilation (NIV) of continuous nasopharyngeal O2 with
      intermittent close/open nose and abdomen compression (PO2-NC-AC) can provide effective
      oxygenation, ventilation and circulation. It needs no any instruments, therefore no limits
      upper and lower airways. Both animal, clinical studies and experiences have already
      demonstrated its safety and efficacy in high risky and severe asphyxiated conditions. Making
      pressure (PEEP and PIP) changes is an essential for creating assist PPV. In children, airway
      lumen images are dynamic and positively correlate to the intraluminal pressure levels, such
      as the lumen open or close pressure. Closely measuring and monitoring these airway pressures
      and associated lumen image changes can benefit for making accurate diagnosis and enhance
      clinical management.

      Purpose: Prospective study to evaluate the dynamic changes of upper and lower airway: 1) PEEP
      and PIP levels; and 2) the associated changes of lumen image by using FB with this NIV
      technique in small children with airway anomaly.

      Study candidates: Children who: a) need FB examination or management for clinical reasons; b)
      age ≤5 year-old; and c) with airway anomaly; will enroll to this study. Expect enrolls a
      total of 30 children in one-year period.

      Methods: As usually doing the FB with cardiopulmonary monitor and this NIV support in
      pediatric intensive care unit settings. A small catheter connects the inner cannel of FB and
      links to a pressure monitor. During course of FB, records the intra-airway lumen pressures
      (PEEP, PIP) and takes associated images. Total record (study) time in each enrolled case
      about 5 minutes. This study will not prolong the FB time. Finally, analysis these associated
      data.

      Prediction: This study (30 enrolled cases) can smoothly complete in one-year period.

      Benefits: This modality of FB with NIV may: 1) more safely doing; 2) get scientific data to
      prove it's efficacy; and 3) benefit for both clinical diagnosis and management; in children
      with airway anomaly.
    

Detailed description: 
      -  As usually doing the FB with cardiopulmonary monitor and this NIV support in pediatric
           intensive care unit settings.

        -  A small catheter connects the inner cannel of FB and links to a pressure monitor.

        -  During course of FB, records the intra-lumen pressures (PEEP, PIP) and takes associated
           images at assigned 6 airway locations, if possible.

        -  These 6 locations are: Oropharynx, Supra-glottis, Mid-trachea, Supra-carina Right main
           bronchus, and Left main bronchus.

        -  Thus, a complete FB would involve 6 pairs of measurements in each child.

        -  Both results of PIP levels and images were then stored in a computer for later analysis.

        -  Total record (study) time in each enrolled case about 5 minutes. This study will not
           prolong the FB time. Finally, analysis these associated data.

        -  For objective evaluation of the lumen changes, three captured images were grouped by 6
           locations in each child. These lumen dimensions were independently judged on a
           five-point Likert scale (1 to 5: very collapse, collapse, average, expansion, very
           expansion) within one week by four qualified pediatric bronchoscopists who were blinded
           to the source of these images. The final scores were averaged and analyzed.

        -  Statistical Analysis: The categorical variables were described as percentages and
           compared with the Chi-square or Fisher's exact test as appropriate. A two-tailed p <0.05
           was considered to be statistically significant.
    

Intervention name(s): NIV rate: 0/min; NIV rate: 10-20/min; NIV rate: 5-10/min
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): A basic PhO2 flow was routinely provided. A small pharyngeal catheter with warmed, humidified and fixed pure oxygen flow was inserted via one nostril to ensured catheter tip positioning in the oropharynx. The NIV was performed in the following steps. Firmly closed the mouth, then intermittently applied a) assisted inspiration by nose-closure accompanied with cricoid depression; and b) assisted expiration by the release of above nose and cricoid maneuver but with simultaneous abdomen-compression. The above assisted ventilation cycle was maintained at a rate of 0-20 cycles per minute. The scopist executed both the FB and the nose-closure and release, whereas an assistant delivered the abdomen compression.; A basic PhO2 flow was routinely provided. A small pharyngeal catheter with warmed, humidified and fixed pure oxygen flow was inserted via one nostril to ensured catheter tip positioning in the oropharynx. The NIV was performed in the following steps. Firmly closed the mouth, then intermittently applied a) assisted inspiration by nose-closure accompanied with cricoid depression; and b) assisted expiration by the release of above nose and cricoid maneuver but with simultaneous abdomen-compression. The above assisted ventilation cycle was maintained at a rate of 0-20 cycles per minute. The scopist executed both the FB and the nose-closure and release, whereas an assistant delivered the abdomen compression.; A basic PhO2 flow was routinely provided. A small pharyngeal catheter with warmed, humidified and fixed pure oxygen flow was inserted via one nostril to ensured catheter tip positioning in the oropharynx. The NIV was performed in the following steps. Firmly closed the mouth, then intermittently applied a) assisted inspiration by nose-closure accompanied with cricoid depression; and b) assisted expiration by the release of above nose and cricoid maneuver but with simultaneous abdomen-compression. The above assisted ventilation cycle was maintained at a rate of 0-20 cycles per minute. The scopist executed both the FB and the nose-closure and release, whereas an assistant delivered the abdomen compression.
Intervention model: Single Group Assignment
Intervention model description: Upon the pharyngeal oxygen setting, this classic NIV operation was performed as per our protocol illustrated in the following steps. Firmly closed the mouth, then intermittently applied: a) assisted inspiration by nose-closure accompanied with cricoid depression; and b) assisted expiration by the release of above nose and cricoid maneuver, and simultaneous doing abdomen-compression. The above assisted ventilation cycle was performed at a rate of 0-20 cycles per minute. The bronchoscopist optionally executed both the FB and the nose- closure and release, whereas an assistant delivered the abdomen-compression.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: airway pressure; bronchomalacia; tracheomalacia; positive pressure ventilation; airway expansion; noninvasive ventilation