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Tracheal Dilatation in Pediatric Patients With Acquired Tracheal Stenosis, and the Effects of Apneic Oxygenation

NCT ID: NCT05028023

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2022-08-31

Brief Summary

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The study presents an alternative method of tracheal dilatation in pediatric patients with acquired tracheal stenosis. Dilatation is performed by the use of balloon catheter connected with manometer, that is bronchoscopic guided into trachea in the stenotic area, through the wide canal of supraglottic device i-Gel. Every dilatation cession consists of three consequent tracheal balloon dilatations of maximum 3 minutes duration each, followed by 10-15minutes interval of controlled ventilation. The balloon is inflated for 60 seconds to reach predefined pressure, and then deflated. This method is minimal traumatic for tracheal mucosa, and application of several dilatation procedures every 2-3months, in pediatric patients with acquired tracheal stenosis, may lead to a relative reopening of trachea and recession of clinical symptoms.For the right performance of the dilatation procedure, patients receive general anesthesia with cessation of spontaneous ventilation. During procedure, controlled ventilation-oxygenation is impossible, because the i-Gel canal is occupied by bronchoscope and balloon catheter, so patients will remain apneic for a short period of time. For pediatric patients is important to perform proper preoxygenation prior to procedure, and to maintain oxygenation as long as possible during procedure. This is achieved by application of apneic oxygenation, through a small catheter, connected to high flow oxygen. Participants are exposed during first dilation to no oxygenation, while during second and third dilatation to apneic oxygenation. Aim of the study is to investigate primarily whether application of apneic oxygenation, in pediatric patients during tracheal balloon dilatation, maintains regional cerebral oxygen saturation rSO2 in significant higher levels, compared with no application of oxygenation. rSO2 levels are a sensitive index of oxygenation efficacy of the brain, accordingly this refers to a safe procedure. Secondary issues are whether application of apneic oxygenation maintains pulse oximetry SpO2 and artierial oxygen partial pressure PaO2 in higher levels, and what are the effects on arterial carbon dioxide partial pressure PaCO2 and on haemodynamic parameters (heart rate, blood pressure), compared with no application of apneic oxygenation.

Detailed Description

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The study is taking place in the Bronchoscopy Unit of the 3rd Pediatric Dpt of the Aristotles University of Thessaloniki, in the area of the Operating Rooms in the Hippokratic General Hospital of Thessaloniki, Greece. The procedure of tracheal balloon dilatation was developed and performed in Hippokratic General Hospital of Thessaloniki, Greece, for the last three years. From October 2020, pediatric patients are recruited and enrolled in this study, according to specific criteria, set by the Collaborators of the Pulmonology and Bronchoscopy Unit of the 3rd Pediatric Dpt of Aristotles University of Thessaloniki, Greece. Prior to the dilatation procedure, following steps are necessary, performed by the Principal Investigator:

1.detailed preanesthetic evaluation of the participant, for recognition of clinical signs or pathology, that can complicate the procedure and jeopardize health status 2. written informed consents from parents/caregivers, for anesthesia procedure, for tracheal dilatation procedure, and for participation in the study. All recordings during procedures are performed by the Principal Investigator, and double checked by two Collaborators.In cases of appearance of adverse events during the procedure (i.e. severe desaturation, anaphylactic reaction, severe bronchospasm), it is automatically discontinued, advanced life support is initiated, anesthesia is terminated, and participants are closely monitored during recovery.

Sample size calculation was performed according to G\* power analysis 3.1.9.2. and the Means test: for extraction of results is necessary to record at least five different pediatric patients, who will undergo at least four tracheal dilatation cessions.

For statistical analysis, quantitative variables will be described as median values and standard deviation (or IQR), qualitative variables as frequencies and percentages, while significancy level will be defined as \<0.05.

Conditions

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Apnea+Hypopnea Tracheal Dilatation Igel Tracheal Stenosis Cerebral Hypoxia Pediatric Respiratory Diseases

Keywords

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Apneic oxygenation Tracheal stenosis Tracheal dilatation by Balloon Catheter i-Gel Regional cerebral oxygen saturation rSO2 by NIRS Peripheral oxygen saturation SpO2 Partial pressure of arterial oxygen PaO2 Partial pressure of arterial carbon dioxide PaCO2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This single arm Interventional Study is a comparative clinical trial with the form of before and after intervention (apneic oxygenation), in every participant. During the phases of before and after intervention, parameters of regional cerebral oxygen saturation, peripheral oxygen saturation, arterial blood gases and haemodynamics are recorded in both conditions.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pediatric patients with tracheal stenosis undergoing tracheal balloon dilatation

Pediatric patients with severe to median acquired tracheal stenosis undergoing tracheal balloon dilatation, and the effects of apneic oxygenation on regional cerebral oxygen saturation rSO2, pulse oximetry SpO2, and arterial oxygen partial pressure PaO2

Group Type EXPERIMENTAL

Apneic oxygenation - supplemental high flow oxygen administration by an apneic way

Intervention Type BIOLOGICAL

In pediatric patients undergoing tracheal balloon dilatation, oxygenation maintenance is essential, while induction in anesthesia, cessation of spontaneous ventilation by neuromuscular relaxant and pediatric i-gel placement are necessary for access to trachea. After i-Gel placement controlled ventilation with 100% oxygen is initiated. Pediatric bronchoscope and balloon dilatation catheter are advanced into trachea to the stenotic area. Overall dilatation duration is 2,5-3minutes, while the balloon is inflated for 60sec. Every dilatation cession consists of three dilatations. First dilatation is performed without oxygen enrichment. During second and third dilatation, a nelaton catheter, connected with high oxygen flow, is advanced into i-Gel canal, together with bronchoscope and balloon catheter. Effects of no oxygenation and apneic oxygenation in regional cerebral oxygen saturation rSO2, pulse oximetry SpO2, arterial blood gases and haemodynamics are recorded and compared.

Interventions

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Apneic oxygenation - supplemental high flow oxygen administration by an apneic way

In pediatric patients undergoing tracheal balloon dilatation, oxygenation maintenance is essential, while induction in anesthesia, cessation of spontaneous ventilation by neuromuscular relaxant and pediatric i-gel placement are necessary for access to trachea. After i-Gel placement controlled ventilation with 100% oxygen is initiated. Pediatric bronchoscope and balloon dilatation catheter are advanced into trachea to the stenotic area. Overall dilatation duration is 2,5-3minutes, while the balloon is inflated for 60sec. Every dilatation cession consists of three dilatations. First dilatation is performed without oxygen enrichment. During second and third dilatation, a nelaton catheter, connected with high oxygen flow, is advanced into i-Gel canal, together with bronchoscope and balloon catheter. Effects of no oxygenation and apneic oxygenation in regional cerebral oxygen saturation rSO2, pulse oximetry SpO2, arterial blood gases and haemodynamics are recorded and compared.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Persistent clinical signs of inspiratory stridor, combined with high pitched cry, hoarse voice, persistent cough or recurrent inspiratory tract infections
* Bronchoscopic conferment of tracheal stenosis from the subglottic area to the area above carina
* Maintenance of clinical symptoms despite intensive and long drug therapy with inhalational steroids, adrenalin or salbutamol
* Urgent need for expansion of trachea, because of risk of full obstruction of trachea

Exclusion Criteria

* children with haemodynamic instability prior or during the procedure
* children with active respiratory tract infection
* children with low hemoglobin levels - anemia
* children with physical status, according to the American Society of Anesthesiologists, III and IV
* parents who refuse the participation of their children in the study and to sign the informed consent
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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IORDANIDOU DESPOINA

MD, Pediatric Anesthetist, Senior Consultant, Anesthesiology Dpt, Hippokratic General Hospital Thessaloniki, Greece

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Despoina Iordanidou, Consultant

Role: PRINCIPAL_INVESTIGATOR

Hippokratio General Hospital, Thessaloniki, Greece

Locations

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Hippokratio General Hospital

Thessaloniki, Thessaloniki, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Despoina Iordanidou, MD, MSc

Role: CONTACT

Phone: 00306944223403

Email: [email protected]

Ioannis Tsanakas, MD, PHD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Despoina Iordanidou, MD, MSc

Role: primary

Ioannis Tsanakas, Professor

Role: backup

References

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Soneru CN, Hurt HF, Petersen TR, Davis DD, Braude DA, Falcon RJ. Apneic nasal oxygenation and safe apnea time during pediatric intubations by learners. Paediatr Anaesth. 2019 Jun;29(6):628-634. doi: 10.1111/pan.13645. Epub 2019 Apr 29.

Reference Type BACKGROUND
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Brown SB, Hedlund GL, Glasier CM, Williams KD, Greenwood LH, Gilliland JD. Tracheobronchial stenosis in infants: successful balloon dilation therapy. Radiology. 1987 Aug;164(2):475-8. doi: 10.1148/radiology.164.2.3602388.

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Reference Type RESULT
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Maresh A, Preciado DA, O'Connell AP, Zalzal GH. A comparative analysis of open surgery vs endoscopic balloon dilation for pediatric subglottic stenosis. JAMA Otolaryngol Head Neck Surg. 2014 Oct;140(10):901-5. doi: 10.1001/jamaoto.2014.1742.

Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT

Vukovic AA, Hanson HR, Murphy SL, Mercurio D, Sheedy CA, Arnold DH. Apneic oxygenation reduces hypoxemia during endotracheal intubation in the pediatric emergency department. Am J Emerg Med. 2019 Jan;37(1):27-32. doi: 10.1016/j.ajem.2018.04.039. Epub 2018 Apr 18.

Reference Type RESULT
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Kolettas A, Grosomanidis V, Kolettas V, Zarogoulidis P, Tsakiridis K, Katsikogiannis N, Tsiouda T, Kiougioumtzi I, Machairiotis N, Drylis G, Kesisis G, Beleveslis T, Zarogoulidis K. Influence of apnoeic oxygenation in respiratory and circulatory system under general anaesthesia. J Thorac Dis. 2014 Mar;6 Suppl 1(Suppl 1):S116-45. doi: 10.3978/j.issn.2072-1439.2014.01.17.

Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Other Identifiers

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4637/25-06-2019

Identifier Type: -

Identifier Source: org_study_id