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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000038733 |
Receipt No. | R000044006 |
Scientific Title | The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Ranrandomised Controlled Trial |
Date of disclosure of the study information | 2019/12/02 |
Last modified on | 2019/11/29 |
Basic information | ||
Public title | The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Ranrandomised Controlled Trial | |
Acronym | Apneic Oxyganation by Nasal Canula in Neonate and Infant | |
Scientific Title | The Effect of Nasal Canula prior to Tracheal Intubation on Preventing Hypoxemia in Neonate and Infant : a Double-blind,Ranrandomised Controlled Trial | |
Scientific Title:Acronym | Apneic Oxyganation by Nasal Canula in Neonate and Infant | |
Region |
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Condition | ||
Condition | Neonate and infant who require intubation under general anesthesia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the effect of oxygen administration using a nasal cannula during intubation in neonate and infant. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Time from the start of intubation until SpO2 drops to 95%. |
Key secondary outcomes | 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. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | NO |
Dynamic allocation | |
Institution consideration | |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | 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. |
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Interventions/Control_2 | We administer 0.2L/kg/min oxygen to patients in group 2. | |
Interventions/Control_3 | We administer 1.0L/kg/min oxygen to patients in group 3. | |
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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. |
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Key exclusion criteria | Rapid sequence induction
Emergency case Predicted difficult airways Differential lung ventilation Heart and cardiovascular disease Congenital heart disease and respiratory disease |
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Target sample size | 240 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama Children's Medical Center | ||||||
Division name | Anesthesiology | ||||||
Zip code | 330-8777 | ||||||
Address | 1-2 Shintoshin, Chuou-ku, Saitama, Japan | ||||||
TEL | 048-601-2200 | ||||||
sishida-bb@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Saitama Children's Medical Center | ||||||
Division name | Anesthesiology | ||||||
Zip code | 330-8777 | ||||||
Address | 1-2 Shintoshin, Chuou-ku, Saitama, Japan | ||||||
TEL | 048-601-2200 | ||||||
Homepage URL | |||||||
sishida-bb@umin.ac.jp |
Sponsor | |
Institute | Saitama Children's Medical Center |
Institute | |
Department |
Funding Source | |
Organization | non |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Saitama Children's Medical Center Ethics Committee |
Address | 1-2 Shintoshin, Chuou-ku, Saitama, Japan |
Tel | 048-601-2200 |
fujihira.tatsuhiko@pref.saitama.lg.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | 2019-04-001 |
Org. issuing International ID_1 | Saitama Children's Medical Center Ethics Committee |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
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Baseline Characteristics | |
Participant flow | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044006 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |