Unique ID issued by UMIN | UMIN000038733 |
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Receipt number | R000044006 |
Scientific Title | The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Randomised Controlled Trial |
Date of disclosure of the study information | 2019/12/02 |
Last modified on | 2022/02/17 00:43:52 |
The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Randomised Controlled Trial
Apneic Oxyganation by Nasal Canula in Neonate and Infant
The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Randomised Controlled Trial
Apneic Oxyganation by Nasal Canula in Neonate and Infant
Japan |
Neonate and infant who require intubation under general anesthesia
Anesthesiology |
Others
NO
To investigate the effect of oxygen administration using a nasal cannula during intubation in neonate and infant.
Efficacy
Exploratory
Pragmatic
Not applicable
Time from the start of intubation until SpO2 drops to 95%.
1)Time and SpO2 from the start of intubation to the end of the first or second intubation. Time and SpO2 until the re-mask ventilation.
2)SpO2 every 15 seconds from intubation start to completion.
3)Extract cases that required time for intubation and compare the lowest SpO2 by group.
4)Incidence of complications from oxygen administration from nasal cannula.
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
NO
YES
Central registration
3
Prevention
Maneuver |
After the induction of general anesthesia, we will attach an atom nasal cannula to all patients but administer oxygen to control group patients (group 1).
We provide patient ventilation with 100% FiO2. After muscle relaxation, we stop mask ventilation to patients and start intubation.
We administer 0.2L/kg/min oxygen to patients in group 2.
We administer 1.0L/kg/min oxygen to patients in group 3.
Not applicable |
24 | months-old | > |
Male and Female
1) Men and women who have general anesthesia at our hospital for 0 months or more and less than 24 months.
2) Patients with ASA-PS1 or 2.
3) When the patient's representative shows sufficient understanding and consents to participate.
Rapid sequence induction
Emergency case
Predicted difficult airways
Differential lung ventilation
Heart and cardiovascular disease
Congenital heart disease and respiratory disease
240
1st name | Sachi |
Middle name | |
Last name | Ishida |
Saitama Children's Medical Center
Anesthesiology
330-8777
1-2 Shintoshin, Chuou-ku, Saitama, Japan
048-601-2200
sishida-bb@umin.ac.jp
1st name | Sachi |
Middle name | |
Last name | Ishida |
Saitama Children's Medical Center
Anesthesiology
330-8777
1-2 Shintoshin, Chuou-ku, Saitama, Japan
048-601-2200
sishida-bb@umin.ac.jp
Saitama Children's Medical Center
non
Other
Saitama Children's Medical Center Ethics Committee
1-2 Shintoshin, Chuou-ku, Saitama, Japan
048-601-2200
fujihira.tatsuhiko@pref.saitama.lg.jp
YES
2019-04-001
Saitama Children's Medical Center Ethics Committee
2019 | Year | 12 | Month | 02 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 11 | Month | 14 | Day |
2019 | Year | 11 | Month | 14 | Day |
2019 | Year | 12 | Month | 02 | Day |
2020 | Year | 12 | Month | 31 | Day |
2019 | Year | 11 | Month | 29 | Day |
2022 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044006
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