At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan
In Brief
A clinical study evaluating NIV rate: 0/min, NIV rate: 10-20/min, and 1 other intervention for Airway Disease. Completed, enrolled 30 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.