Clinical trial NCT05028023: Tracheal Dilatation in Pediatric Patients With Acquired Tracheal Stenosis, and the Effects of Apneic Oxygenation
Official title: Effects of Apneic Oxygenation in Regional Cerebral Oxygen Saturation rSO2 During Tracheal Dilatation Procedures in Pediatric Patients (With Acquired Tracheal Stenosis). Innovation and Safety of the Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of changes in regional cerebral oxygen saturation rSO2 between first and second tracheal balloon dilatation procedure in children
timeFrame: Changes in regional cerebral oxygen saturation rSO2 between end and strart of first/second tracheal dilatation procedure
measure: Comparison of changes in regional cerebral oxygen saturation rSO2 between first and third tracheal balloon dilatation procedure in children
timeFrame: Changes in regional cerebral oxygen saturation rSO2 between end and strart of first/third tracheal dilatation procedure
measure: Comparison of changes in regional cerebral oxygen saturation rSO2 between second and third tracheal balloon dilatation procedure in children
timeFrame: Changes in regional cerebral oxygen saturation rSO2 between end and strart of second/third tracheal dilatation procedure
Secondary outcomes:
measure: Comparison of changes in pulse oximetry - oxygen saturation SpO2 between first and second tracheal dilatation procedure in children
timeFrame: Changes in pulse oximetry SpO2 between end and start of first/second tracheal dilatation procedure in children
measure: Comparison of changes in pulse oximetry - oxygen saturation SpO2 between first and third tracheal dilatation procedure in children
timeFrame: Changes in pulse oximetry SpO2 between end and start of first/third tracheal dilatation procedure in children
measure: Comparison of changes in arterial oxygen partial pressure PaO2 between first and second tracheal dilatation procedure in children
timeFrame: Changes of arterial oxygen partial pressure PaO2 between end and start of first/second tracheal balloon dilatation procedure in children
measure: Comparison of changes in arterial oxygen partial pressure PaO2 between first and third tracheal dilatation procedure in children
timeFrame: Changes of arterial oxygen partial pressure PaO2 between end and start of first/third tracheal balloon dilatation procedure in children
measure: Comparison of changes in arterial carbon dioxide partial pressure PaCO2 between first and second tracheal dilatation procedure in children
timeFrame: Changes of arterial carbon dioxide partial pressure PaCO2 between end and start of first/second tracheal balloon dilatation procedure in children
measure: Comparison of changes in arterial carbon dioxide partial pressure PaCO2 between first and third tracheal dilatation procedure in children
timeFrame: Changes of arterial carbon dioxide partial pressure PaCO2 between end and start of first/third tracheal balloon dilatation procedure in children
measure: Comparison of changes in acid-base balance PH between first and second tracheal dilatation procedure in children
timeFrame: Changes in acid-base balanc PH between end and start of first/second tracheal balloon dilatation procedure in children
measure: Comparison of changes in acid-base balance PH between first and third tracheal dilatation procedure in children
timeFrame: Changes in acid-base balance PH between end and start of first/third tracheal balloon dilatation procedure in children
measure: Comparison of changes in Bicarbonate plasma levels HCO3, between first and second tracheal dilatation procedure in children
timeFrame: Changes in Bicarbonate plasma levels HCO3 between end and start of first/second tracheal balloon dilatation procedure in childre
measure: Comparison of changes in Bicarbonate plasma levels HCO3, between first and third tracheal dilatation procedure in children
timeFrame: Changes in HCO3 between end and start of first/third tracheal balloon dilatation procedure in children
measure: Comparison of changes in Lactate plasma levels Lac, between first and second tracheal dilatation procedure in children
timeFrame: Changes in Lactate plasma levels Lac between end and start of first/second tracheal balloon dilatation procedure in children
measure: Comparison of changes in Lactate plsama levels Lac, between first and third tracheal dilatation procedure in children
timeFrame: Changes in Lactate plasma levels Lac between end and start of first/third tracheal balloon dilatation procedure in children
measure: Comparison of changes in Heart Rate, between first and second tracheal dilatation procedure in children
timeFrame: Changes in Heart Rate between end and start of first/second tracheal balloon dilatation procedure in children
measure: Comparison of changes in Heart Rate, between first and third tracheal dilatation procedure in children
timeFrame: Changes in Heart Rate between end and start of first/third tracheal balloon dilatation procedure in children
measure: Comparison of changes in Systolic Blood Pressure, between first and second tracheal dilatation procedure in children
timeFrame: Changes in Systolic Blood Pressure between end and start of first/second tracheal balloon dilatation procedure in children
measure: Comparison of changes in Systolic Blood Pressure, between first and third tracheal dilatation procedure in children
timeFrame: Changes in Systolic Blood Pressure between end and start of first/third tracheal balloon dilatation procedure in children
measure: Comparison of changes in Diastolic Blood Pressure, between first and second tracheal dilatation procedure in children
timeFrame: Changes in Diastolic Blood Pressure between end and start of first/second tracheal balloon dilatation procedure in children
measure: Comparison of changes in Diastolic Blood Pressure, between first and third tracheal dilatation procedure in children
timeFrame: Changes in Diastolic Blood Pressure between end and start of first/third tracheal balloon dilatation procedure in children
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Hippokratio General Hospital
state: Thessaloniki
Study officials:
affiliation: Hippokratio General Hospital, Thessaloniki, Greece
name: Despoina Iordanidou, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Kernisan G, Adler E, Gibbons P, Runions B (1987). Apneic oxygenation in pediatric patients. Anesthesiology; 67(3A).
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.