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Airway Pressure and Lumen Changes During NIV With Flexible Bronchoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666403
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.


Condition or disease Intervention/treatment Phase
Airway Disease Procedure: NIV rate: 0/min Procedure: NIV rate: 10-20/min Procedure: NIV rate: 5-10/min Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description: Three modes with different ventilation (nose-close) rates were studied: mode A, spontaneous breathing, with only PhO2 support, no rate; mode B, rate of 15-20 per minute with Ti 1.0 seconds; and mode C, rate of 5-10 per minute with Ti 2-4 seconds. During FB, every patient underwent all these three modes sequentially, from A to C. When the oxygen desaturation (<90%) or bradycardia (<100 beat/min) persisted more than 10 seconds, the FB was terminated. After the child was stabilized, FB was resumed, starting from the nose-close, but shifted to the next mode of NIV support. When the mode C still failed to maintain an acceptable vital status, the FB procedure was aborted with the removal of the bronchoscope to allow more aggressive NIV or even traditional resuscitation technique including endotracheal intubation and manual ventilation with high FiO2.
Primary Purpose: Diagnostic
Official Title: Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 13, 2018

Arm Intervention/treatment
Experimental: Patients
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.
Procedure: NIV rate: 0/min
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.

Procedure: NIV rate: 10-20/min
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.

Procedure: NIV rate: 5-10/min
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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Intra-airway lumen expansion [ Time Frame: intra-procedure, when the tips of FB locate in the assigned airway location ]
    When doing these 3 modes of NIV, take and measure the lumen expansion at 6 different airway locations.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666403


Locations
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Taiwan
Taipei-Veterans General Hospital
Taipei, Taiwan, 11217
Teipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Director: Wen-Jue Soong University of Alberta

Publications of Results:

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03666403    
Other Study ID Numbers: 2017-07-009B
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: When these data are reasonable for this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
airway pressure
bronchomalacia
tracheomalacia
positive pressure ventilation
airway expansion
noninvasive ventilation