Airway DiseaseNCT03666403
Airway Pressure and Lumen Changes During NIV With Flexible Bronchoscopy
A study testing NIV rate: 0/min, NIV rate: 10-20/min and NIV rate: 5-10/min in people with Airway Disease, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Disease
- What is being tested?
- NIV rate: 0/min, NIV rate: 10-20/min and NIV rate: 5-10/min
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jan 2018to 13 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei-Veterans General Hospital
Taipei, 11217
Teipei Veterans General Hospital
Taipei, 112
About this study
Official title: Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan
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.
Read more
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.
Read the 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.
- Conditions
- Airway Disease
- Being tested
- NIV rate: 0/min, NIV rate: 10-20/min, NIV rate: 5-10/min
- Keywords
- airway pressure, bronchomalacia, tracheomalacia, positive pressure ventilation, airway expansion, noninvasive ventilation
- Medical subject headings
- Bronchomalacia, Tracheomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV rate: 0/minProcedure or surgery
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.
NIV rate: 10-20/minProcedure or surgery
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.
NIV rate: 5-10/minProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | This prospective one-year study enrolled consecutive 30 children of ≤3 years-old with suspected major airway diseases and therefore scheduled for diagnostic FB. During FB, PIP measurements and associated lumen images were obtained at six airway locations using three studied NIV modes, including 1) NIV rate: 0/min, 2) NIV rate: 10-20/min, 3) NIV rate: 5-10/min. Receives: Procedure: NIV rate: 0/min; Procedure: NIV rate: 10-20/min; Procedure: NIV rate: 5-10/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intra-procedure, when the tips of FB locate in the assigned airway location
Secondary outcomes (1)
Intra-airway lumen expansion
When doing these 3 modes of NIV, take and measure the lumen expansion at 6 different airway locations.
Measured: intra-procedure, when the tips of FB locate in the assigned airway location
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wen-Jue Soong, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666403
- Sponsor's protocol ID
- 2017-07-009B
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When these data are reasonable for this study.
Publications
Lin YT, Lee YS, Jeng MJ, Chen WY, Tsao PC, Chan IC, Soong WJ. Flexible bronchoscopic findings and the relationship to repeated extubation failure in critical children. J Chin Med Assoc. 2018 Sep;81(9):804-810. doi: 10.1016/j.jcma.2018.03.008. Epub 2018 May 31.
PubMed 29861210Soong WJ, Tsao PC, Lee YS, Yang CF. Flexible endoscopy for pediatric tracheobronchial metallic stent placement, maintenance and long-term outcomes. PLoS One. 2018 Feb 8;13(2):e0192557. doi: 10.1371/journal.pone.0192557. eCollection 2018.
PubMed 29420596Soong WJ, Tsao PC, Lee YS, Yang CF. Therapeutic flexible airway endoscopy of small children in a tertiary referral center-11 years' experience. PLoS One. 2017 Aug 17;12(8):e0183078. doi: 10.1371/journal.pone.0183078. eCollection 2017.
PubMed 28817604Soong WJ, Tsao PC, Lee YS, Yang CF. Retrieval of tracheobronchial foreign bodies by short flexible endoscopy in children. Int J Pediatr Otorhinolaryngol. 2017 Apr;95:109-113. doi: 10.1016/j.ijporl.2017.01.033. Epub 2017 Feb 16.
PubMed 28576517Soong 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.
PubMed 26188901Yang CF, Niu DM, Jeng MJ, Lee YS, Taso PC, Soong WJ. Late-onset Pompe disease with left-sided bronchomalacia. Respir Care. 2015 Feb;60(2):e26-9. doi: 10.4187/respcare.03419. Epub 2014 Oct 14.
PubMed 25316892Soong WJ, Jeng MJ, Lee YS, Tsao PC, Harloff M, Matthew Soong YH. A novel technique of non-invasive ventilation: Pharyngeal oxygen with nose-closure and abdominal-compression--Aid for pediatric flexible bronchoscopy. Pediatr Pulmonol. 2015 Jun;50(6):568-75. doi: 10.1002/ppul.23028. Epub 2014 Mar 10.
PubMed 24616304Soong WJ, Jeng MJ, Lee YS, Tsao PC, Soong YH. Nasopharyngeal oxygen with intermittent nose-close and abdomen-compression: a novel resuscitation technique in a piglet model. Pediatr Pulmonol. 2013 Mar;48(3):288-94. doi: 10.1002/ppul.22592. Epub 2012 May 2.
PubMed 22553182Soong WJ, Lee YS, Tsao PC, Yang CF, Jeng MJ. Comparison of oxygenation among different supplemental oxygen methods during flexible bronchoscopy in infants. J Chin Med Assoc. 2011 Dec;74(12):556-60. doi: 10.1016/j.jcma.2011.09.016. Epub 2011 Oct 28.
PubMed 22196471Soong WJ, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Pediatric obstructive fibrinous tracheal pseudomembrane--characteristics and management with flexible bronchoscopy. Int J Pediatr Otorhinolaryngol. 2011 Aug;75(8):1005-9. doi: 10.1016/j.ijporl.2011.04.020. Epub 2011 Jun 2.
PubMed 21640393Peng YY, Soong WJ, Lee YS, Tsao PC, Yang CF, Jeng MJ. Flexible bronchoscopy as a valuable diagnostic and therapeutic tool in pediatric intensive care patients: a report on 5 years of experience. Pediatr Pulmonol. 2011 Oct;46(10):1031-7. doi: 10.1002/ppul.21464. Epub 2011 May 27.
PubMed 21626712Soong WJ, Shiao AS, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Comparison between rigid and flexible laser supraglottoplasty in the treatment of severe laryngomalacia in infants. Int J Pediatr Otorhinolaryngol. 2011 Jun;75(6):824-9. doi: 10.1016/j.ijporl.2011.03.016. Epub 2011 Apr 21.
PubMed 21513991Soong WJ, Lee YS, Soong YH, Tsao PC, Yang CF, Jeng MJ, Peng YY. Tracheal foreign body after laser supraglottoplasty: a hidden but risky complication of an aluminum foil tape-wrapped endotracheal tube. Int J Pediatr Otorhinolaryngol. 2010 Dec;74(12):1432-4. doi: 10.1016/j.ijporl.2010.08.019. Epub 2010 Oct 8.
PubMed 20934755Chen WT, Soong WJ, Lee YS, Jeng MJ, Chang HL, Hwang B. The safety of aerodigestive tract flexible endoscopy as an outpatient procedure in young children. J Chin Med Assoc. 2008 Mar;71(3):128-34. doi: 10.1016/S1726-4901(08)70004-2.
PubMed 18364264Soong WJ. Endoscopic intubation with aid of mechanical ventilation via a dedicated nasopharyngeal airway. J Chin Med Assoc. 2007 Sep;70(9):400-2. doi: 10.1016/S1726-4901(08)70028-5.
PubMed 17908656
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT03666403
- Acronym / sponsor ID
- 2017-07-009B
- Conditions
- Airway Disease
- Keywords
- airway pressure, bronchomalacia, tracheomalacia, positive pressure ventilation, airway expansion, noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: NIV rate: 0/min, Procedure: NIV rate: 10-20/min, Procedure: NIV rate: 5-10/minThis prospective one-year study enrolled consecutive 30 children of ≤3 years-old with suspected major airway diseases and therefore scheduled for diagnostic FB. During FB, PIP measurements and associated lumen images were obtained at six airway locations using three studied NIV modes, including 1) NIV rate: 0/min, 2) NIV rate: 10-20/min, 3) NIV rate: 5-10/min. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV rate: 0/minA 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. | Procedure or surgery | Patients |
| NIV rate: 10-20/minA 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. | Procedure or surgery | Patients |
| NIV rate: 5-10/minA 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. | Procedure or surgery | Patients |
Primary outcome
Intra- airway Positive inspiration pressure (PIP)
Time frame: intra-procedure, when the tips of FB locate in the assigned airway location
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
1 secondary outcome
Intra-airway lumen expansion
Time frame: intra-procedure, when the tips of FB locate in the assigned airway location
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Results publication: PubMed 29861210Lin YT, Lee YS, Jeng MJ, Chen WY, Tsao PC, Chan IC, Soong WJ. Flexible bronchoscopic findings and the relationship to repeated extubation failure in critical children. J Chin Med Assoc. 2018 Sep;81(9):804-810. doi: 10.1016/j.jcma.2018.03.008. Epub 2018 May 31.
- Results publication: PubMed 29420596Soong WJ, Tsao PC, Lee YS, Yang CF. Flexible endoscopy for pediatric tracheobronchial metallic stent placement, maintenance and long-term outcomes. PLoS One. 2018 Feb 8;13(2):e0192557. doi: 10.1371/journal.pone.0192557. eCollection 2018.
- Results publication: PubMed 28817604Soong WJ, Tsao PC, Lee YS, Yang CF. Therapeutic flexible airway endoscopy of small children in a tertiary referral center-11 years' experience. PLoS One. 2017 Aug 17;12(8):e0183078. doi: 10.1371/journal.pone.0183078. eCollection 2017.
- Results publication: PubMed 28576517Soong WJ, Tsao PC, Lee YS, Yang CF. Retrieval of tracheobronchial foreign bodies by short flexible endoscopy in children. Int J Pediatr Otorhinolaryngol. 2017 Apr;95:109-113. doi: 10.1016/j.ijporl.2017.01.033. Epub 2017 Feb 16.
- Results publication: PubMed 26188901Soong 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.
- Results publication: PubMed 25316892Yang CF, Niu DM, Jeng MJ, Lee YS, Taso PC, Soong WJ. Late-onset Pompe disease with left-sided bronchomalacia. Respir Care. 2015 Feb;60(2):e26-9. doi: 10.4187/respcare.03419. Epub 2014 Oct 14.
- Results publication: PubMed 24616304Soong WJ, Jeng MJ, Lee YS, Tsao PC, Harloff M, Matthew Soong YH. A novel technique of non-invasive ventilation: Pharyngeal oxygen with nose-closure and abdominal-compression--Aid for pediatric flexible bronchoscopy. Pediatr Pulmonol. 2015 Jun;50(6):568-75. doi: 10.1002/ppul.23028. Epub 2014 Mar 10.
- Results publication: PubMed 22553182Soong WJ, Jeng MJ, Lee YS, Tsao PC, Soong YH. Nasopharyngeal oxygen with intermittent nose-close and abdomen-compression: a novel resuscitation technique in a piglet model. Pediatr Pulmonol. 2013 Mar;48(3):288-94. doi: 10.1002/ppul.22592. Epub 2012 May 2.
- Results publication: PubMed 22196471Soong WJ, Lee YS, Tsao PC, Yang CF, Jeng MJ. Comparison of oxygenation among different supplemental oxygen methods during flexible bronchoscopy in infants. J Chin Med Assoc. 2011 Dec;74(12):556-60. doi: 10.1016/j.jcma.2011.09.016. Epub 2011 Oct 28.
- Results publication: PubMed 21640393Soong WJ, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Pediatric obstructive fibrinous tracheal pseudomembrane--characteristics and management with flexible bronchoscopy. Int J Pediatr Otorhinolaryngol. 2011 Aug;75(8):1005-9. doi: 10.1016/j.ijporl.2011.04.020. Epub 2011 Jun 2.
- Results publication: PubMed 21626712Peng YY, Soong WJ, Lee YS, Tsao PC, Yang CF, Jeng MJ. Flexible bronchoscopy as a valuable diagnostic and therapeutic tool in pediatric intensive care patients: a report on 5 years of experience. Pediatr Pulmonol. 2011 Oct;46(10):1031-7. doi: 10.1002/ppul.21464. Epub 2011 May 27.
- Results publication: PubMed 21513991Soong WJ, Shiao AS, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Comparison between rigid and flexible laser supraglottoplasty in the treatment of severe laryngomalacia in infants. Int J Pediatr Otorhinolaryngol. 2011 Jun;75(6):824-9. doi: 10.1016/j.ijporl.2011.03.016. Epub 2011 Apr 21.
- Individual participant dataSharing planned: Undecided. When these data are reasonable for this study.
Related trials for Airway Disease
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Jue Soong study director
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV rate: 0/min, NIV rate: 10-20/min and NIV rate: 5-10/min in people with Airway Disease, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra- airway Positive inspiration pressure (PIP) (time frame: intra-procedure, when the tips of FB locate in the assigned airway location). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666403, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.