Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 2:49 PM
Study NCT ID:
NCT03666403
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airway Pressure and Lumen Changes During NIV With Flexible Bronchoscopy
Sponsor:
Taipei Veterans General Hospital, Taiwan
Organization:
Study Overview
Official Title:
Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: