- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06659887
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
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.
Přehled studie
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Faiyum Governorate
-
Al Fayyum, Faiyum Governorate, Egypt, 63514
- Fayoum University Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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 .
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
Ostatní jména:
|
|
Aktivní komparátor: 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
Ostatní jména:
|
|
Aktivní komparátor: 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
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
rise of arterial pressure of carbon dioxide
Časové okno: between 120s and 180s time points of apnea
|
mmHg |
between 120s and 180s time points of apnea
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to oxygen desaturation
Časové okno: 5 seconds after the onset of apnea
|
below 95% |
5 seconds after the onset of apnea
|
|
Number of patients reached 6 minutes of apnea
Časové okno: 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
Časové okno: 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
Časové okno: at the beginning of apnea
|
mmHg |
at the beginning of apnea
|
|
Mean difference in arterial pressure of oxygen
Časové okno: at the end of apnea time
|
mmHg |
at the end of apnea time
|
|
Lowest recorded oxygen saturation
Časové okno: throughout the apneic oxygenation
|
in percentage (%) |
throughout the apneic oxygenation
|
|
Heart rate
Časové okno: Before anaesthetizing child
|
beat/minute |
Before anaesthetizing child
|
|
Mean arterial blood pressure
Časové okno: Before anaesthetizing child
|
mmHg |
Before anaesthetizing child
|
|
Heart rate
Časové okno: During apnea time
|
beat/minute |
During apnea time
|
|
Mean arterial blood pressure
Časové okno: During apnea time
|
mmHg |
During apnea time
|
|
Occurence of sore throat
Časové okno: in first postoperative day
|
Yes or no |
in first postoperative day
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Age
Časové okno: 1 hour preoperatively
|
Years |
1 hour preoperatively
|
|
Weight
Časové okno: 1 hour preoperatively
|
Kilogram |
1 hour preoperatively
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Safaa G Ragab, MD, Fayoum University
- Ředitel studie: Ahmed A Lotfy, MD, Fayoum University
Publikace a užitečné odkazy
Obecné publikace
- Li S, Hsieh TC, Rehder KJ, Nett S, Kamat P, Napolitano N, Turner DA, Adu-Darko M, Jarvis JD, Krawiec C, Derbyshire AT, Meyer K, Giuliano JS Jr, Tala J, Tarquinio K, Ruppe MD, Sanders RC Jr, Pinto M, Howell JD, Parker MM, Nuthall G, Shepherd M, Emeriaud G, Nagai Y, Saito O, Lee JH, Simon DW, Orioles A, Walson K, Vanderford P, Shenoi A, Lee A, Bird GL, Miksa M, Graciano AL, Bain J, Skippen PW, Polikoff LA, Nadkarni V, Nishisaki A; for National Emergency Airway Registry for Children (NEAR4KIDS) and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Frequency of Desaturation and Association With Hemodynamic Adverse Events During Tracheal Intubations in PICUs. Pediatr Crit Care Med. 2018 Jan;19(1):e41-e50. doi: 10.1097/PCC.0000000000001384.
- Parker MM, Nuthall G, Brown C 3rd, Biagas K, Napolitano N, Polikoff LA, Simon D, Miksa M, Gradidge E, Lee JH, Krishna AS, Tellez D, Bird GL, Rehder KJ, Turner DA, Adu-Darko M, Nett ST, Derbyshire AT, Meyer K, Giuliano J Jr, Owen EB, Sullivan JE, Tarquinio K, Kamat P, Sanders RC Jr, Pinto M, Bysani GK, Emeriaud G, Nagai Y, McCarthy MA, Walson KH, Vanderford P, Lee A, Bain J, Skippen P, Breuer R, Tallent S, Nadkarni V, Nishisaki A; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Relationship Between Adverse Tracheal Intubation Associated Events and PICU Outcomes. Pediatr Crit Care Med. 2017 Apr;18(4):310-318. doi: 10.1097/PCC.0000000000001074.
- Dias R, Dave N, Chhabria R, Shah H, Garasia M. A randomised comparative study of Miller laryngoscope blade versus Oxiport(R) Miller laryngoscope blade for neonatal and infant intubations. Indian J Anaesth. 2017 May;61(5):404-409. doi: 10.4103/ija.IJA_86_17.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
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