Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children
NCT ID: NCT06742476
Last Updated: 2024-12-19
Study Results
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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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2024-12-15
2025-04-15
Brief Summary
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In modern practice, apneic oxygenation during airway management denotes the uninterrupted supply of oxygen, extending the window for maintaining safe oxygen saturation levels during the apneic phase . This technique holds particular significance in pediatric patients undergoing adenotonsillectomy, where the delicate balance of oxygenation is paramount .
Adenotonsillectomy, a common surgical procedure in pediatric patients, poses unique challenges in airway management . The procedure involves the removal of the adenoids and tonsils, often necessitating general anesthesia and temporary airway obstruction . Furthermore, the potential for blood and secretions in the oropharynx increases the risk of airway compromise during the perioperative period. In this context, ensuring adequate oxygenation is essential to mitigate the risk of hypoxemia and its associated complications In this randomized clinical trial, the investigators aim to evaluate the efficacy and safety of apneic oxygenation using nasal cannula in pediatric patients undergoing adenotonsillectomy under general anesthesia. By assessing our primary outcome and secondary outcomes, the investigators seek to contribute valuable insights into optimizing anesthesia management protocols for this vulnerable patient population.
Detailed Description
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Prior to recruitment and randomization, detailed consent will be obtained from the parents or legal guardians of eligible patients.
Patients were randomly allocated 1: 1 to the two study groups:
Group (A):
Patients in the group A will undergo tracheal intubation without apneic oxygenation
Group (B):
Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula The randomization will be computer generated random number and the randomization sequence will be kept hidden in sealed opaque envelopes just opened after recruitment and admittance to the operating room. The group's allocations will be only blinded to parents of children.
In both the control and experimental groups, subjects will undergo a standardized general anesthesia protocol. All pediatric participants will receive premedication in the form of 0.5 mg/kg rectal midazolam upon admission to the operating theater, patients will be comfortably positioned on the operating table. Standard monitoring devices, including electrocardiography (ECG), non-invasive blood pressure (NIBP) measurement, pulse oximetry, and end-tidal carbon dioxide (EtCO2) monitoring, will be affixed. Intravenous access will be established to facilitate fluid and medication administration. In instances where venous access proves challenging, patients will be induced with inhaled sevoflurane at 8% concentration, followed by the insertion of an intravenous cannula. Subsequently, anesthetic induction will be achieved using a combination of 2 - 3 mg/kg of Propofol, 1 mcg/kg of Fentanyl, and 0.5 mg/kg of Atracurium. Following induction, bag-mask ventilation with 100% oxygen and flow rates of 6-8 litres min will be initiated for 3 minutes Ventilation will then be discontinued. In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.
Following intubation, SpO2 levels will be recorded, and mechanical ventilation will be instituted to maintain normocapnia and oxygenation within predetermined target ranges.
In case of desaturation, the procedure will be discontinued as soon as the SpO2 reach 92%. Bag mask ventilation with 100% oxygen will be started until spo2 reach 100%, Intubation will then be performed by the supervising consultant anesthesiologist
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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control group
Patients in the group A will undergo tracheal intubation without apneic oxygenation
No interventions assigned to this group
apniec oxygenation group
Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula
nasal cannula
In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.
Interventions
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nasal cannula
In the apneic oxygenation group, nasal cannula will be employed to administer continuous oxygenation, utilizing a flow rate of 0.2 L/kg, during the apneic phase while tracheal intubation is performed. Successful intubation will be confirmed by auscultation and the appearance of a square wave capnogragh.
Eligibility Criteria
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Inclusion Criteria
* Patients who were scheduled for adenotonsillectomy.
* ASA I and II
Exclusion Criteria
* Patients reported with nasal obstruction.
* Patients with any respiratory disease like asthma or recent upper respiratory tract infection.
* Patients with obstructive sleep apnea
* Patients with congenital heart disease
* Patients suspected difficult intubation or syndromatic patients eg : down syndrome , Goldenhar Syndrome , Pierre Robin syndrome … etc
3 Years
10 Years
ALL
No
Sponsors
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Fayoum University Hospital
OTHER
Responsible Party
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Safaa Gaber Ragab
Associate professor of anaesthiology
Principal Investigators
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Safaa Gaber Ragab, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of medicine, Fayoum university
Central Contacts
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References
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Bhananker SM, Ramamoorthy C, Geiduschek JM, Posner KL, Domino KB, Haberkern CM, Campos JS, Morray JP. Anesthesia-related cardiac arrest in children: update from the Pediatric Perioperative Cardiac Arrest Registry. Anesth Analg. 2007 Aug;105(2):344-50. doi: 10.1213/01.ane.0000268712.00756.dd.
van Munster JJCM, Zamanipoor Najafabadi AH, Schoones JW, Peul WC, van den Hout WB, van Benthem PPG. The impact of new evidence on regional variation in paediatric tonsillectomy and adenoidectomy: a historical review. J Laryngol Otol. 2020 Dec;134(12):1036-1043. doi: 10.1017/S002221512000273X.
Noda M, Shimada MD, Koshu R, Saito C, Ito M. Efficacy of endoscopic powered intracapsular tonsillectomy and adenoidectomy for pediatric obstructive sleep apnea: A retrospective case-control study. Auris Nasus Larynx. 2023 Jun;50(3):383-388. doi: 10.1016/j.anl.2022.08.008. Epub 2022 Sep 7.
Randall DA. Current Indications for Tonsillectomy and Adenoidectomy. J Am Board Fam Med. 2020 Nov-Dec;33(6):1025-1030. doi: 10.3122/jabfm.2020.06.200038.
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.
Olayan L, Alatassi A, Patel J, Milton S. Apnoeic oxygenation by nasal cannula during airway management in children undergoing general anaesthesia: a pilot randomised controlled trial. Perioper Med (Lond). 2018 Feb 21;7:3. doi: 10.1186/s13741-018-0083-x. eCollection 2018.
Lyons C, Callaghan M. Uses and mechanisms of apnoeic oxygenation: a narrative review. Anaesthesia. 2019 Apr;74(4):497-507. doi: 10.1111/anae.14565. Epub 2019 Feb 19.
Kleine-Brueggeney M, Grosshauser M, Greif R. Apneic oxygenation in pediatric anesthesia. Curr Opin Anaesthesiol. 2022 Jun 1;35(3):361-366. doi: 10.1097/ACO.0000000000001127.
Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
Tiradentes TAA, Einav S, Braz JRC, Nunes-Nogueira VS, Betini M, Corrente JE, Braz MG, Braz LG. Global anaesthesia-related cardiac arrest rates in children: a systematic review and meta-analysis. Br J Anaesth. 2023 Nov;131(5):901-913. doi: 10.1016/j.bja.2023.08.023. Epub 2023 Sep 22.
Other Identifiers
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M738
Identifier Type: -
Identifier Source: org_study_id