Clinical trial NCT03666403: Airway Pressure and Lumen Changes During NIV With Flexible Bronchoscopy
Official title: Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Disease
Keywords: airway pressure
bronchomalacia
tracheomalacia
positive pressure ventilation
airway expansion
noninvasive ventilation
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

* age no more than 3 years old
* a natural airway lumen without prior plasty;
* difficult weaning from current respiratory support and therefore
* scheduled for elective FB for highly suspected airway problems.

Exclusion Criteria:

* uncontrollable cardiopulmonary failure
* body weight less than 2.0 kg
* bleeding tendency.
* fixed/ too narrowed airways where the FB (OD 3.8 mm) could not pass through

Primary outcomes:
measure: Intra- airway Positive inspiration pressure (PIP)
timeFrame: intra-procedure, when the tips of FB locate in the assigned airway location
Secondary outcomes:
measure: Intra-airway lumen expansion
timeFrame: intra-procedure, when the tips of FB locate in the assigned airway location
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei-Veterans General Hospital
city: Taipei
country: Taiwan
facility: Teipei Veterans General Hospital
Study officials:
affiliation: University of Alberta
name: Wen-Jue Soong
role: STUDY_DIRECTOR
References:
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citation: Soong WJ, Tsao PC, Lee YS, Yang CF, Liao J, Jeng MJ. Retrieving difficult aspirated pen caps by balloon catheter with short working-length flexible endoscopy and noninvasive ventilation support in intensive care unit. Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1484-9. doi: 10.1016/j.ijporl.2015.06.033. Epub 2015 Jul 3.
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citation: Soong WJ, Jeng MJ, Hwang B. The application of a modified mini-flexible-fiberoptic endoscopy in pediatric practice. Zhonghua Yi Xue Za Zhi (Taipei). 1995 Nov;56(5):338-44.
citation: Soong WJ, Jeng MJ, Hwang B. Direct tracheobronchial suction for massive post-extubation atelectasis in premature infants. Zhonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi. 1996 Jul-Aug;37(4):266-71.
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