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Clinical Trials/NCT06742476
NCT06742476CompletedNot Applicable

Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children Undergoing Adenotonsillectomy (As Partially Obstructed Airway)

Fayoum University Hospital1 site in 1 country140 target enrollmentStarted: December 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
140
Locations
1
Primary Endpoint
Lowest oxygen saturation during tracheal intubation.

Study Overview

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.

Detailed Description

Following permission from the local institutional review board and institutional ethics committee, this study will be carried out at the FAYOUM University hospital. The research will employ a single -blinded, randomized, and controlled approach.

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
3 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

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

Intervention: nasal cannula (Device)

Outcomes

Primary Outcomes

Lowest oxygen saturation during tracheal intubation.

Time Frame: at the end of intubation procedure

Following intubation, SpO2 levels will be recorded

Secondary Outcomes

  • 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)
  • Time of intubation.(at the end of intubation procedure)
  • Number of patients developed bradycardia.(at the end of the study ( 6 months ))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Safaa Gaber Ragab

Associate professor of anaesthiology

Fayoum University Hospital

Study Sites (1)

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