UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038481 |
|---|---|
| Receipt number | R000043849 |
| Scientific Title | Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure |
| Date of disclosure of the study information | 2019/11/03 |
| Last modified on | 2021/11/20 18:05:06 |
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Basic information
Public title
Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Acronym
Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Scientific Title
Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Scientific Title:Acronym
Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Region
| Japan |
Condition
Condition
acute respiratory failure
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of Jackson mask ventilation in bronchoscopy of patients with ARF
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oxygenation during bronchoscopy
Key secondary outcomes
oxygen flow rate during bronchoscopy, inspection time, amount of the drug for sedation, and complications rate after inspection
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The adult patients who were undergone bronchoscopy in our institute from January 2015 to May 2018
2) patients had ARF status before and during bronchoscopy
Also, each group has definied the following criteria.
3) If patients did without Jackson mask ventilation, they needed ARF status before bronchoscopy.
4) If patients did with Jackson mask ventilation, they needed ARF status before and during bronchoscopy.
Key exclusion criteria
1) the patients who needed intubation
2) the patients who were using Jackson mask ventilation preventively
3) the patients who principal investigator deemed inappropriate for incorporation into research
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Suzuki |
Organization
National Center for Global Health and Medicine
Division name
Respiratory
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
msuzuki@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takumida |
Organization
National Center for Global Health and Medicine
Division name
Respiratory
Zip code
162-8655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
htakumida@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Certified Review Board of National Center for Global Health and Medicine
Address
1-21-1 Toyama, shinzyuku,Tokyo 162-8655, Japan
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人 国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
https://journals.lww.com/md-journal/Fulltext/2021/11190/Usefulness_of_Jackson_mask_ventilation_durin
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/md-journal/Fulltext/2021/11190/Usefulness_of_Jackson_mask_ventilation_durin
Number of participants that the trial has enrolled
25
Results
12 were classified into the Jackson group and 13 into the conventional group. Proper oxygenation was maintained in the Jackson group, with SpO2 increasing after Jackson mask ventilation (89.4% to 96.8%, P = .03). Mean SpO2 was significantly higher in the Jackson group than in the conventional group (96.8% vs 95.2%, P = .03). Mean oxygen flow rate was significantly lower in the Jackson group (4.0 L/min vs 7.9 L/min, P < .001). There was no significant difference in safety.
Results date posted
| 2021 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Under submission
Date of the first journal publication of results
Baseline Characteristics
We retrospectively reviewed patients with acute respiratory failure who underwent bronchoscopy at our institution between January 2015 and May 2018.
Participant flow
We compared patients who received Jackson mask ventilation (Jackson group) and those who received conventional oxygen administration (conventional group). We excluded patients who were intubated and those without acute respiratory failure who received Jackson mask ventilation preventively.
Adverse events
There were no significant difference between two groups in terms of adverse events.
Outcome measures
Mean percutaneous oxygen saturation (SpO2) and mean oxygen flow rate were compared between the groups by the Wilcoxon signed-rank test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study. We extract the following medical information from the medical records.
Back grounds, Vital signs before and during bronchoscopy, Respiratory status, Type and amount of drugs used for sedation, Final diagnosis, Complications, and Outcome
Management information
Registered date
| 2019 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043849
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