Apnea
Conditions
Keywords
Low flow rate, Children, Gas exchange
Brief summary
Background: Children desaturate rapidly during apnea following anesthetic induction. The optimal apneic oxygenation flow rate and its effect on CO2 accumulation remain unclear. Objective: To compare nasal oxygen at 2, 4, and 8 L/min on the rise in arterial partial pressure of CO2 (PaCO2) between minutes 2 and 3 of apnea (primary outcome), oxygenation, and safety in anesthetized children.
Detailed description
Introduction Patients undergoing general anesthesia with neuromuscular blockade experience a period of apnea between cessation of mask ventilation and initiation of mechanical ventilation. This interval is particularly critical in infants and toddlers, who are prone to rapid desaturation because of higher oxygen consumption and lower functional residual capacity than older children and adults \[1\]. Accordingly, hypoxemia during induction and airway manipulation is associated with an increased incidence of postoperative complications and serious adverse events, including death \[2,3\]. Apneic oxygenation refers to the continuous insufflation of oxygen into the airway during apnea \[4\]. Several studies have shown that this approach effectively maintains oxygenation and reduces the risk of hypoxemia during tracheal intubation \[5,6\]. An ongoing challenge in pediatric anesthesia is to ensure adequate oxygenation while limiting lung volume loss and carbon dioxide accumulation during apnea, particularly during airway manipulation. Therefore, techniques that extend the duration of safe apnea without introducing additional risks are of considerable clinical relevance \[7\]. Accordingly, apneic oxygenation has gained attention as an adjunctive technique, with similar benefits reported in children using both low-flow and high-flow nasal oxygen, although pediatric data remain more limited \[8\]. Multiple studies have examined low-flow apneic oxygenation in children, showing that it reduces the incidence of hypoxemia and extends the duration of safe apnea, in some reports by up to several minutes, compared with no apneic oxygenation. Comparative data on CO2 kinetics across different low-flow rates in children are limited \[9-11\]. Therefore, this study aimed to examine the effect of different flow oxygen rates applied during a standardized 6-minute period of apnea on the increase in arterial partial pressure of CO2 (PaCO2) in anesthetized, paralyzed children. Sample size No previous data were available for the primary outcome, the rise in PaCO₂ between the 2nd and 3rd minutes of apnea (ΔPaCO₂, mmHg), so a pilot study of five children per group was performed. These pilot children were a separate, non-randomized cohort and were excluded from the modified intention-to-treat analysis. The mean ± SD ΔPaCO₂ was 4.2 ± 1.6, 3.4 ± 1.5 and 2.8 ± 1.4 mmHg at 2, 4 and 8 L/min. The largest difference (2 vs 8 L/min) was 1.4 mmHg, a one-third reduction, considered clinically meaningful as it would delay hypercapnia and respiratory acidosis during apnea; the pooled SD for these two groups was 1.5 mmHg (Cohen's d = 0.93). For three pairwise comparisons with 1:1:1 allocation, a two-sided alpha of 0.0167 (0.05/3) and 80% power, at least 26 children per group were required (independent-samples t-test, G\*Power 3.1.9.7), used as an approximation for the three-group ANOVA design. Allowing for 15% loss of data, 30 children were enrolled per group (90 total).
Interventions
After induction, bag-mask ventilation with 100% oxygen and flow rates of 6 L/ min will be carried out until the expired oxygen concentration will be \>90%, saturation of oxygen was 100%, and end tidal carbon dioxide was 30-40 mmHg. Once this will be reached, bag-mask ventilation will be stopped and apneic oxygenation will be initiated for 3 minutes
Sponsors
Study design
Masking description
Due to the clinically obvious oxygen administration modalities, study personnel in theatres cannot be blinded, but patients and parents will be blinded to group allocation.
Eligibility
Inclusion criteria
* Children aged 1 to 6 years old weighting 10-20 kg. * American Society of Anesthesiologists (ASA) physical status I or II. * Children will be scheduled for elective surgery under general anesthesia.
Exclusion criteria
* Parent refusal * Patient required nasal intubation * Children with a cardio-respiratory disease like asthma or recent upper respiratory infection. * Anemia. * Obstructive sleep apnea, sepsis. * Children prone to hypoxia or hypercarbia, and upper airway obstruction. * Children reported to have nasal obstruction .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rise of arterial pressure of carbon dioxide | between 120s and 180s time points of apnea | mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to oxygen desaturation | 5 seconds after the onset of apnea | below 95% |
| Number of patients reached 6 minutes of apnea | 1 minute after end of apneic oxygenation | Count number of patients in each group |
| Pressure difference between the end-tidal carbon dioxide and the arterial carbon dioxide | Between the end of apnea and the preceding blood gas | mmHg |
| Mean difference in arterial pressure of oxygen | at the beginning of apnea | mmHg |
| Lowest recorded oxygen saturation | throughout the apneic oxygenation | in percentage (%) |
| Heart rate | Before anaesthetizing child | beat/minute |
| Mean arterial blood pressure | Before anaesthetizing child | mmHg |
| Occurence of sore throat | in first postoperative day | Yes or no |
Countries
Egypt
Contacts
Fayoum University
Fayoum University