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Different Flow Rates on Gas Exchange in Children During Apnea

11. oktober 2026 opdateret af: Yasser S Mostafa, MD

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

    • Faiyum Governorate
      • Al Fayyum, Faiyum Governorate, Egypten, 63514
        • Fayoum University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 6 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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 .

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Low group

Low flow 100% O2 AT 2 L/min

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

Andre navne:
  • iltnæsekanyle
Aktiv komparator: Moderate group

Low flow 100% O2 AT 4 L/min

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

Andre navne:
  • iltnæsekanyle
Aktiv komparator: High group

Low flow 100% O2 AT 8 L/min

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

Andre navne:
  • iltnæsekanyle

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
rise of arterial pressure of carbon dioxide
Tidsramme: between 120s and 180s time points of apnea

mmHg

between 120s and 180s time points of apnea

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to oxygen desaturation
Tidsramme: 5 seconds after the onset of apnea

below 95%

5 seconds after the onset of apnea
Number of patients reached 6 minutes of apnea
Tidsramme: 1 minute after end of apneic oxygenation

Count number of patients in each group

1 minute after end of apneic oxygenation
Pressure difference between the end-tidal carbon dioxide and the arterial carbon dioxide
Tidsramme: Between the end of apnea and the preceding blood gas

mmHg

Between the end of apnea and the preceding blood gas
Mean difference in arterial pressure of oxygen
Tidsramme: at the beginning of apnea

mmHg

at the beginning of apnea
Mean difference in arterial pressure of oxygen
Tidsramme: at the end of apnea time

mmHg

at the end of apnea time
Lowest recorded oxygen saturation
Tidsramme: throughout the apneic oxygenation

in percentage (%)

throughout the apneic oxygenation
Heart rate
Tidsramme: Before anaesthetizing child

beat/minute

Before anaesthetizing child
Mean arterial blood pressure
Tidsramme: Before anaesthetizing child

mmHg

Before anaesthetizing child
Heart rate
Tidsramme: During apnea time

beat/minute

During apnea time
Mean arterial blood pressure
Tidsramme: During apnea time

mmHg

During apnea time
Occurence of sore throat
Tidsramme: in first postoperative day

Yes or no

in first postoperative day

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Age
Tidsramme: 1 hour preoperatively

Years

1 hour preoperatively
Weight
Tidsramme: 1 hour preoperatively

Kilogram

1 hour preoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Safaa G Ragab, MD, Fayoum University
  • Studieleder: Ahmed A Lotfy, MD, Fayoum University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2024

Primær færdiggørelse (Faktiske)

1. maj 2026

Studieafslutning (Faktiske)

1. juni 2026

Datoer for studieregistrering

Først indsendt

24. oktober 2024

Først indsendt, der opfyldte QC-kriterier

24. oktober 2024

Først opslået (Faktiske)

26. oktober 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

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