Skip to content

Different Flow Rates on Gas Exchange in Children During Apnea

Effect of Nasal Oxygen at 2, 4, and 8 L/Min on PaCO₂ and PaO₂ During Apneic Oxygenation in Anesthetized Children: A Prospective Randomized Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06659887
Enrollment
90
Registered
2024-10-26
Start date
2024-11-01
Completion date
2026-06-01
Last updated
2026-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea

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

Yasser S Mostafa, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

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

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No

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

MeasureTime frameDescription
rise of arterial pressure of carbon dioxidebetween 120s and 180s time points of apneammHg

Secondary

MeasureTime frameDescription
Time to oxygen desaturation5 seconds after the onset of apneabelow 95%
Number of patients reached 6 minutes of apnea1 minute after end of apneic oxygenationCount number of patients in each group
Pressure difference between the end-tidal carbon dioxide and the arterial carbon dioxideBetween the end of apnea and the preceding blood gasmmHg
Mean difference in arterial pressure of oxygenat the beginning of apneammHg
Lowest recorded oxygen saturationthroughout the apneic oxygenationin percentage (%)
Heart rateBefore anaesthetizing childbeat/minute
Mean arterial blood pressureBefore anaesthetizing childmmHg
Occurence of sore throatin first postoperative dayYes or no

Countries

Egypt

Contacts

STUDY_DIRECTORSafaa G Ragab, MD

Fayoum University

STUDY_DIRECTORAhmed A Lotfy, MD

Fayoum University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 14, 2026