Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children Undergoing Adenotonsillectomy (As Partially Obstructed Airway)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fayoum University Hospital
- 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
Patients in the group A will undergo tracheal intubation without apneic oxygenation
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
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
Safaa Gaber Ragab
Associate professor of anaesthiology
Fayoum University Hospital
