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NCT03666403 Clinical Trial

Airway Pressure and Lumen Changes During NIV With Flexible Bronchoscopy

Airway Disease Clinical Trial

Official title:
Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03666403
Other study ID # 2017-07-009B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date July 13, 2018

Study information
Verified date September 2018
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

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Locations
Country Name City State
Taiwan Taipei-Veterans General Hospital Taipei
Taiwan Teipei Veterans General Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (29)

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Outcome
Type Measure Description Time frame Safety issue
Primary Intra- airway Positive inspiration pressure (PIP) When doing these 3 modes of NIV, measure the intra-airway PIP at 6 assigned different locations.
When doing this NIV, measure the PIP at 6 different airway locations		 intra-procedure, when the tips of FB locate in the assigned airway location
Secondary Intra-airway lumen expansion When doing these 3 modes of NIV, take and measure the lumen expansion at 6 different airway locations. intra-procedure, when the tips of FB locate in the assigned airway location
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