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Apnea+HypopneaNCT05028023

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

A study testing Apneic oxygenation - supplemental high flow oxygen administration by an apneic way in people with Apnea+Hypopnea and Tracheal Dilatation, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 14 years
Conditions the study is for
Apnea+Hypopnea, Tracheal Dilatation, Igel
What is being tested?
Apneic oxygenation - supplemental high flow oxygen administration by an apneic way
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteGreece
Study dates
21 Oct 2020to 31 Aug 2022
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 2 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Despoina Iordanidou, MD, MSc contact

00306944223403

desiord@yahoo.gr

Ioannis Tsanakas, MD, PHD contact

tsanakasj@gmail.com

Greece1 site, 1 recruiting

  • Hippokratio General Hospital

    Thessaloniki, Thessaloniki, 54642

    Despoina Iordanidou, MD, MSc, 00306944223403, desiord@yahoo.gr

    Ioannis Tsanakas, Professor, tsanakasj@gmail.com

    Recruiting

Other trials in Greece

About this study

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

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.

Read the 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.

Being tested
Apneic oxygenation - supplemental high flow oxygen administration by an apneic way
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
Medical subject headings
Ige Responsiveness, Atopic, Tracheal Stenosis, Hypoxia, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apneic oxygenation - supplemental high flow oxygen administration by an apneic wayBiological

    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.

Study groups in NCT05028023
Study groupRoleWhat they receive
Pediatric patients with tracheal stenosis undergoing tracheal balloon dilatationExperimentalPediatric 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
Receives: Biological: Apneic oxygenation - supplemental high flow oxygen administration by an apneic way

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (18)

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

    Evaluation of changes in pulse oximetry - oxygen saturation SpO2 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in SpO2 between 1st and 2nd tracheal balloon dilatation in children. Higher oxygen saturation SpO2 levels, in the case of apneic oxygenation application, compared to no oxygen enrichment, are expected.

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

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

    Evaluation of changes in pulse oximetry - oxygen saturationSpO2 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in SpO2 between 1st and 3rd tracheal balloon dilatation in children. Higher oxygen saturation SpO2 levels, in the case of apneic oxygenation application, compared to no oxygen enrichment, are expected.

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

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

    Evaluation of changes in arterial oxygen partial pressure PaO2 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in PaO2 between 1st and 2nd tracheal balloon dilatation in children. Higher arterial oxygen partial pressure PaO2 levels, in the case of apneic oxygenation application, compared to no oxygen enrichment, are expected.

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

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

    Evaluation of changes in arterial oxygen partial pressure PaO2 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in PaO2 between 1st and 3rd tracheal balloon dilatation in children. Higher arterial oxygen partial pressure PaO2 levels, in the case of apneic oxygenation application, compared to no oxygen enrichment, are expected.

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

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

    Evaluation of changes in arterial carbon dioxide partial pressure PaCO2 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in PaCO2 between 1st and 2nd tracheal balloon dilatation in children. High arterial carbon dioxide partial pressure PaCO2 levels, in both no apneic and apneic oxygenation application cases are expected, and the rate of PaCO2 increase depends on the duration of apnea.

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

  6. Comparison of changes in arterial carbon dioxide partial pressure PaCO2 between first and third tracheal dilatation procedure in children

    Evaluation of changes in arterial carbon dioxide partial pressure PaCO2 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in PaCO2 between 1st and 3rd tracheal balloon dilatation in children. High PaCO2 levels, in both no apneic and apneic oxygenation application cases are expected, and the rate of arterial carbon dioxide partial pressure PaCO2 increase depends on the duration of apnea.

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

  7. Comparison of changes in acid-base balance PH between first and second tracheal dilatation procedure in children

    Evaluation of changes in acid-base balanc PH between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in PH between 1st and 2nd tracheal balloon dilatation in children. An equal decrease in acid-base balanc PH, in both no apneic and apneic oxygenation application cases is expected, and the rate of this decrease depends on the duration of apnea and the subsequent arterial carbon dioxide partial pressure PaCO2 increase.

    Measured: Changes in acid-base balanc PH between end and start of first/second tracheal balloon dilatation procedure in children

  8. Comparison of changes in acid-base balance PH between first and third tracheal dilatation procedure in children

    Evaluation of changes in acid-base balance PH between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in PH between 1st and 3rd tracheal balloon dilatation in children. An equal decrease in acid-base balance PH, in both no apneic and apneic oxygenation application cases is expected, and the rate of this decrease depends on the duration of apnea and the subsequent arterial carbon dioxide partial pressure PaCO2 increase.

    Measured: Changes in acid-base balance PH between end and start of first/third tracheal balloon dilatation procedure in children

  9. Comparison of changes in Bicarbonate plasma levels HCO3, between first and second tracheal dilatation procedure in children

    Evaluation of changes in Bicarbonate plasma levels HCO3 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in HCO3 levels between 1st and 2nd tracheal balloon dilatation in children. An equal minor decrease in Bicarbonate plasma levels HCO3, in both no apneic and apneic oxygenation application cases is expected, and the rate of this decrease depends on the duration of apnea and the subsequent acid-base balance PH decrease.

    Measured: Changes in Bicarbonate plasma levels HCO3 between end and start of first/second tracheal balloon dilatation procedure in childre

  10. Comparison of changes in Bicarbonate plasma levels HCO3, between first and third tracheal dilatation procedure in children

    Evaluation of changes in Bicarbonate plasma levels HCO3 between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in HCO3 levels between 1st and 3rd tracheal balloon dilatation in children. An equal minor decrease in Bicarbonate plasma levels HCO3, in both no apneic and apneic oxygenation application cases is expected, and the rate of this decrease depends on the duration of apnea and the subsequent acid-base balance PH decrease.

    Measured: Changes in HCO3 between end and start of first/third tracheal balloon dilatation procedure in children

  11. Comparison of changes in Lactate plasma levels Lac, between first and second tracheal dilatation procedure in children

    Evaluation of changes in Lactate plasma levels Lac between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Lac plasma levels between 1st and 2nd tracheal balloon dilatation in children. No changes in Lactate plasma levels Lac, in both no apneic and apneic oxygenation application cases are expected.

    Measured: Changes in Lactate plasma levels Lac between end and start of first/second tracheal balloon dilatation procedure in children

  12. Comparison of changes in Lactate plsama levels Lac, between first and third tracheal dilatation procedure in children

    Evaluation of changes in Lactate plasma levels Lac between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Lac plasma levels between 1st and 3rd tracheal balloon dilatation in children. No changes in Lactate plasma levels Lac, in both no apneic and apneic oxygenation application cases are expected.

    Measured: Changes in Lactate plasma levels Lac between end and start of first/third tracheal balloon dilatation procedure in children

  13. Comparison of changes in Heart Rate, between first and second tracheal dilatation procedure in children

    Evaluation of changes in Heart Rate between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Heart Rate between 1st and 2nd tracheal balloon dilatation in children. No significant changes in Heart Rate, in both no apneic and apneic oxygenation application cases are expected, although lack of oxygen in children leads to bradycardia.

    Measured: Changes in Heart Rate between end and start of first/second tracheal balloon dilatation procedure in children

  14. Comparison of changes in Heart Rate, between first and third tracheal dilatation procedure in children

    Evaluation of changes in Heart Rate between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Heart Rate between 1st and 3rd tracheal balloon dilatation in children. No significant changes in Heart Rate, in both no apneic and apneic oxygenation application cases are expected, although lack of oxygen in children leads to bradycardia.

    Measured: Changes in Heart Rate between end and start of first/third tracheal balloon dilatation procedure in children

  15. Comparison of changes in Systolic Blood Pressure, between first and second tracheal dilatation procedure in children

    Evaluation of changes in Systolic Blood Pressure between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Systolic Blood Pressure between 1st and 2nd tracheal balloon dilatation in children. No significant changes in Systolic Blood Pressure, in both no apneic and apneic oxygenation application cases are expected.

    Measured: Changes in Systolic Blood Pressure between end and start of first/second tracheal balloon dilatation procedure in children

  16. Comparison of changes in Systolic Blood Pressure, between first and third tracheal dilatation procedure in children

    Evaluation of changes in Systolic Blood Pressure between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Systolic Blood Pressure between 1st and 3rd tracheal balloon dilatation in children. No significant changes in Systolic Blood Pressure, in both no apneic and apneic oxygenation application cases are expected.

    Measured: Changes in Systolic Blood Pressure between end and start of first/third tracheal balloon dilatation procedure in children

  17. Comparison of changes in Diastolic Blood Pressure, between first and second tracheal dilatation procedure in children

    Evaluation of changes in Diastolic Blood Pressure between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 2nd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Diastolic Blood Pressure between 1st and 2nd tracheal balloon dilatation in children. No significant changes in Systolic Blood Pressure, in both no apneic and apneic oxygenation application cases are expected.

    Measured: Changes in Diastolic Blood Pressure between end and start of first/second tracheal balloon dilatation procedure in children

  18. Comparison of changes in Diastolic Blood Pressure, between first and third tracheal dilatation procedure in children

    Evaluation of changes in Diastolic Blood Pressure between end and start of 1st tracheal dilatation procedure in children, where no external apneic oxygen enrichment is applied, between end and start of 3rd dilatation procedure, where apneic oxygenation is applied, and comparison of changes in Diastolic Blood Pressure between 1st and 3rd tracheal balloon dilatation in children. No significant changes in Systolic Blood Pressure, in both no apneic and apneic oxygenation application cases are expected.

    Measured: Changes in Diastolic Blood Pressure between end and start of first/third tracheal balloon dilatation procedure in children

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start21 Oct 2020
  3. Primary completion31 Jan 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028023
Sponsor's protocol ID
4637/25-06-2019
Status last verified
Aug 2021
First submitted
5 Aug 2021
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30401594

  • 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.

    PubMed 30943324

  • 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.

    PubMed 3602388

  • 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.

    PubMed 6607627

  • 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.

    PubMed 25170960

  • 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.

    PubMed 22844863

  • 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.

    PubMed 22351854

  • 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.

    PubMed 24192289

  • 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.

    PubMed 13326155

  • 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.

    PubMed 27342820

  • 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.

    PubMed 27152499

  • 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.

    PubMed 22050948

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

  • 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.

    PubMed 29699900

  • 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.

    PubMed 24672687

Questions about this trial

What is this clinical trial studying?

A study testing Apneic oxygenation - supplemental high flow oxygen administration by an apneic way in people with Apnea+Hypopnea and Tracheal Dilatation, run by Aristotle University Of Thessaloniki at 1 site in Greece.

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 5 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Despoina Iordanidou, MD, MSc (00306944223403, desiord@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of changes in regional cerebral oxygen saturation rSO2 between first and second tracheal balloon dilatation procedure in children (time frame: Changes in regional cerebral oxygen saturation rSO2 between end and strart of first/second tracheal dilatation procedure). The study lists 3 primary outcomes in all. 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 NCT05028023, which also lists 22 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 31 Aug 2021.

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