- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Faiyum Governorate
-
Al Fayyum, Faiyum Governorate, Egipt, 63514
- Fayoum University Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 .
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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
Inne nazwy:
|
|
Aktywny 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
Inne nazwy:
|
|
Aktywny 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
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
rise of arterial pressure of carbon dioxide
Ramy czasowe: between 120s and 180s time points of apnea
|
mmHg |
between 120s and 180s time points of apnea
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time to oxygen desaturation
Ramy czasowe: 5 seconds after the onset of apnea
|
below 95% |
5 seconds after the onset of apnea
|
|
Number of patients reached 6 minutes of apnea
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: at the beginning of apnea
|
mmHg |
at the beginning of apnea
|
|
Mean difference in arterial pressure of oxygen
Ramy czasowe: at the end of apnea time
|
mmHg |
at the end of apnea time
|
|
Lowest recorded oxygen saturation
Ramy czasowe: throughout the apneic oxygenation
|
in percentage (%) |
throughout the apneic oxygenation
|
|
Heart rate
Ramy czasowe: Before anaesthetizing child
|
beat/minute |
Before anaesthetizing child
|
|
Mean arterial blood pressure
Ramy czasowe: Before anaesthetizing child
|
mmHg |
Before anaesthetizing child
|
|
Heart rate
Ramy czasowe: During apnea time
|
beat/minute |
During apnea time
|
|
Mean arterial blood pressure
Ramy czasowe: During apnea time
|
mmHg |
During apnea time
|
|
Occurence of sore throat
Ramy czasowe: in first postoperative day
|
Yes or no |
in first postoperative day
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Age
Ramy czasowe: 1 hour preoperatively
|
Years |
1 hour preoperatively
|
|
Weight
Ramy czasowe: 1 hour preoperatively
|
Kilogram |
1 hour preoperatively
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Safaa G Ragab, MD, Fayoum University
- Dyrektor Studium: Ahmed A Lotfy, MD, Fayoum University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- D377
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .