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

NCT05028023 | Unknown

• 1 other identifier: 4637/25-06-2019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Comparison of changes in regional cerebral oxygen saturation rSO2 between first and second tracheal balloon dilatation procedure in children

  Evaluation of changes in regional cerebral oxygen saturation rSO2, measured by Near InfraRed Spectroscopy NIRS, between end and start of 1st tracheal dilatation procedure in children, where no apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in rSO2, between 1st and 2nd procedure. A greater change (decrease) in regional cerebral oxygen saturation rSO2, in the case of no apneic enrichment, compared to apneic oxygenation application, is expected.

  Changes in regional cerebral oxygen saturation rSO2 between end and strart of first/second tracheal dilatation procedure

• Comparison of changes in regional cerebral oxygen saturation rSO2 between first and third tracheal balloon dilatation procedure in children

  Evaluation of changes in regional cerebral oxygen saturation rSO2, measured by Near InfraRed Spectroscopy NIRS, between end and start of 1st tracheal dilatation procedure in children, where no apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in rSO2, between 1st and 3rd procedure. A greater change (decrease) in regional cerebral oxygen saturation rSO2, in the case of no apneic enrichment, compared to apneic oxygenation application, is expected.

  Changes in regional cerebral oxygen saturation rSO2 between end and strart of first/third tracheal dilatation procedure

• Comparison of changes in regional cerebral oxygen saturation rSO2 between second and third tracheal balloon dilatation procedure in children

  Evaluation of changes in regional cerebral oxygen saturation rSO2, measured by Near InfraRed Spectroscopy NIRS, between end and start of 2nd and 3rd tracheal dilatation procedure in children, where in both cases apneic oxygenation is applied, and comparison of changes in rSO2, between 2nd and 3rd procedure. No change in regional cerebral oxygen saturation rSO2, between 2nd and 3rd procedure is expected.

  Changes in regional cerebral oxygen saturation rSO2 between end and strart of second/third tracheal dilatation procedure

Secondary Outcomes (18)

• Comparison of changes in pulse oximetry - oxygen saturation SpO2 between first and second tracheal dilatation procedure in children

  Changes in pulse oximetry SpO2 between end and start of first/second tracheal dilatation procedure in children

• Comparison of changes in pulse oximetry - oxygen saturation SpO2 between first and third tracheal dilatation procedure in children

  Changes in pulse oximetry SpO2 between end and start of first/third tracheal dilatation procedure in children

• Comparison of changes in arterial oxygen partial pressure PaO2 between first and second tracheal dilatation procedure in children

  Changes of arterial oxygen partial pressure PaO2 between end and start of first/second tracheal balloon dilatation procedure in children

• Comparison of changes in arterial oxygen partial pressure PaO2 between first and third tracheal dilatation procedure in children

  Changes of arterial oxygen partial pressure PaO2 between end and start of first/third tracheal balloon dilatation procedure in children

• Comparison of changes in arterial carbon dioxide partial pressure PaCO2 between first and second tracheal dilatation procedure in children

  Changes of arterial carbon dioxide partial pressure PaCO2 between end and start of first/second tracheal balloon dilatation procedure in children

Study Arms (1)

Pediatric patients with tracheal stenosis undergoing tracheal balloon dilatation

EXPERIMENTAL

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

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

Interventions

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

Pediatric patients with tracheal stenosis undergoing tracheal balloon dilatation

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Hippokratio General Hospital

Thessaloniki, Thessaloniki, 54642, Greece

RECRUITING

Related Publications (22)

• Overmann KM, Boyd SD, Zhang Y, Kerrey BT. Apneic oxygenation to prevent oxyhemoglobin desaturation during rapid sequence intubation in a pediatric emergency department. Am J Emerg Med. 2019 Aug;37(8):1416-1421. doi: 10.1016/j.ajem.2018.10.030. Epub 2018 Oct 18.

  PMID: 30401594 BACKGROUND

• 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.

  PMID: 30943324 BACKGROUND

• 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.

  PMID: 3602388 RESULT

• Cohen MD, Weber TR, Rao CC. Balloon dilatation of tracheal and bronchial stenosis. AJR Am J Roentgenol. 1984 Mar;142(3):477-8. doi: 10.2214/ajr.142.3.477. No abstract available.

  PMID: 6607627 RESULT

• 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.

  PMID: 25170960 RESULT

• Whigham AS, Howell R, Choi S, Pena M, Zalzal G, Preciado D. Outcomes of balloon dilation in pediatric subglottic stenosis. Ann Otol Rhinol Laryngol. 2012 Jul;121(7):442-8. doi: 10.1177/000348941212100704.

  PMID: 22844863 RESULT

• Hautefort C, Teissier N, Viala P, Van Den Abbeele T. Balloon dilation laryngoplasty for subglottic stenosis in children: eight years' experience. Arch Otolaryngol Head Neck Surg. 2012 Mar;138(3):235-40. doi: 10.1001/archoto.2011.1439. Epub 2012 Feb 20.

  PMID: 22351854 RESULT

• Lang M, Brietzke SE. A systematic review and meta-analysis of endoscopic balloon dilation of pediatric subglottic stenosis. Otolaryngol Head Neck Surg. 2014 Feb;150(2):174-9. doi: 10.1177/0194599813510867. Epub 2013 Nov 5.

  PMID: 24192289 RESULT

• HOLMDAHL MH. Pulmonary uptake of oxygen, acid-base metabolism, and circulation during prolonged apnoea. Acta Chir Scand Suppl. 1956;212:1-128. No abstract available.

  PMID: 13326155 RESULT

• Mosier JM, Hypes CD, Sakles JC. Understanding preoxygenation and apneic oxygenation during intubation in the critically ill. Intensive Care Med. 2017 Feb;43(2):226-228. doi: 10.1007/s00134-016-4426-0. Epub 2016 Jun 24. No abstract available.

  PMID: 27342820 RESULT

• Ricard JD. Hazards of intubation in the ICU: role of nasal high flow oxygen therapy for preoxygenation and apneic oxygenation to prevent desaturation. Minerva Anestesiol. 2016 Oct;82(10):1098-1106. Epub 2016 May 6.

  PMID: 27152499 RESULT

• Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.

  PMID: 22050948 RESULT

• Kernisan G, Adler E, Gibbons P, Runions B (1987). Apneic oxygenation in pediatric patients. Anesthesiology; 67(3A).

  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.

  PMID: 29699900 RESULT

• 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.

  PMID: 24672687 RESULT

• Pek JH, Tan HC, Shen G, Ong YG. Apneic Oxygenation for Emergency Intubations in the Pediatric Emergency Department-A Quality Improvement Initiative. Pediatr Qual Saf. 2020 Feb 13;5(2):e255. doi: 10.1097/pq9.0000000000000255. eCollection 2020 Mar-Apr.

  PMID: 32426623 RESULT

• Mortimer T, Burzynski J, Kesselman M, Vallance J, Hansen G. Apneic Oxygenation during Rapid Sequence Intubation in Critically Ill Children. J Pediatr Intensive Care. 2016 Mar;5(1):28-31. doi: 10.1055/s-0035-1568149. Epub 2015 Nov 18.

  PMID: 31110879 RESULT

• Scott A, Chua O, Mitchell W, Vlok R, Melhuish T, White L. Apneic Oxygenation for Pediatric Endotracheal Intubation: A Narrative Review. J Pediatr Intensive Care. 2019 Sep;8(3):117-121. doi: 10.1055/s-0039-1678552. Epub 2019 Feb 13.

  PMID: 31404416 RESULT

• Kurth CD, Thayer WS. A multiwavelength frequency-domain near-infrared cerebral oximeter. Phys Med Biol. 1999 Mar;44(3):727-40. doi: 10.1088/0031-9155/44/3/015.

  PMID: 10211806 RESULT

• Kurth CD, Steven JL, Montenegro LM, Watzman HM, Gaynor JW, Spray TL, Nicolson SC. Cerebral oxygen saturation before congenital heart surgery. Ann Thorac Surg. 2001 Jul;72(1):187-92. doi: 10.1016/s0003-4975(01)02632-7.

  PMID: 11465176 RESULT

• Kurth CD, Levy WJ, McCann J. Near-infrared spectroscopy cerebral oxygen saturation thresholds for hypoxia-ischemia in piglets. J Cereb Blood Flow Metab. 2002 Mar;22(3):335-41. doi: 10.1097/00004647-200203000-00011.

  PMID: 11891439 RESULT

• Tsuji M, Saul JP, du Plessis A, Eichenwald E, Sobh J, Crocker R, Volpe JJ. Cerebral intravascular oxygenation correlates with mean arterial pressure in critically ill premature infants. Pediatrics. 2000 Oct;106(4):625-32. doi: 10.1542/peds.106.4.625.

  PMID: 11015501 RESULT

MeSH Terms

Conditions

Ige Responsiveness, Atopic; Tracheal Stenosis; Hypoxia, Brain

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Despoina Iordanidou, Consultant

  Hippokratio General Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Despoina Iordanidou, MD, MSc

CONTACT

00306944223403; desiord@yahoo.gr

Ioannis Tsanakas, MD, PHD

CONTACT

tsanakasj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Pediatric Anesthetist, Senior Consultant, Anesthesiology Dpt, Hippokratic General Hospital Thessaloniki, Greece

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 31, 2021
• Study Start: October 21, 2020
• Primary Completion: January 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)