Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03666403
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2018-08-28
Brief Title:
Airway Pressure and Lumen Changes During NIV With Flexible Bronchoscopy
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
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 closeopen 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 its 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 its 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 Fishers exact test as appropriate A two-tailed p 005 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 Fishers exact test as appropriate A two-tailed p 005 was considered to be statistically significant
Study Oversight
Has Oversight DMC:
None
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?:
None