Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children

NCT06742476 | Completed

• 1 other identifier: M738
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

During general anesthesia, the administration of anesthetics and muscle relaxants induces apnea, wherein spontaneous breathing ceases . Pediatric patients, characterized by their higher oxygen consumption rate and smaller functional residual capacity, are particularly susceptible to hypoxemia during apneic episodes . This vulnerability to hypoxemia underscores the critical need for effective oxygenation strategies during anesthesia. Apneic oxygenation, the provision of oxygen without concurrent tidal volume delivery, emerges as a vital technique in pediatric anesthesia, playing a pivotal role in both routine and challenging airway management scenarios . 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.

Conditions

Airway Obstruction

Outcome Measures

Primary Outcomes (1)

• Lowest oxygen saturation during tracheal intubation.

  Following intubation, SpO2 levels will be recorded

  at the end of intubation procedure

Secondary Outcomes (7)

• Number of patients that their spo2 dropped to 95%.

  at the end of intubation procedure

• Number of patients that their spo2 dropped to 92%.

  at the end of intubation procedure

• Number of patients that their spo2 dropped to below 92%.

  at the end of intubation procedure

• Spo2 base line Spo2 after bag and mask ventillation and Spo2 immediately after intubation.

  at the end of intubation procedure

• Number of intubation attempts.

  at the end of intubation procedure

Study Arms (2)

control group

NO INTERVENTION

Patients in the group A will undergo tracheal intubation without apneic oxygenation

apniec oxygenation group

EXPERIMENTAL

Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula

Device: nasal cannula

Interventions

nasal cannula DEVICE

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.

apniec oxygenation group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients (3 - 10 Years).
• Patients who were scheduled for adenotonsillectomy.
• ASA I and II

You may not qualify if:

• When nasal intubation is needed.
• 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

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Egypt

Location

Related Publications (10)

• 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.

  PMID: 17646488 BACKGROUND

• 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.

  PMID: 33431080 BACKGROUND

• 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.

  PMID: 36085267 BACKGROUND

• 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.

  PMID: 33219085 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

• 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.

  PMID: 29484172 BACKGROUND

• 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.

  PMID: 30784037 BACKGROUND

• 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.

  PMID: 35671025 BACKGROUND

• 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.

  PMID: 28099321 BACKGROUND

• 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.

  PMID: 37743151 RESULT

MeSH Terms

Conditions

Airway Obstruction

Interventions

Cannula

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Safaa Gaber Ragab, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anaesthiology

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 19, 2024
• Study Start: December 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

EG (1)