UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048589 |
|---|---|
| Receipt number | R000055364 |
| Scientific Title | Risk of Postoperative Pneumonia after Extubation with the Positive Pressure versus Normal Pressure Technique: Before and After Observational Study Using the Perioperative Database from the University of Tsukuba Hospital |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2023/08/10 17:51:48 |
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Basic information
Public title
Risk of Postoperative Pneumonia after Extubation with the Positive Pressure versus Normal Pressure Technique: Before and After Observational Study Using a Perioperative Database from the University of Tsukuba Hospital
Acronym
Risk of Postoperative Pneumonia after Extubation with the Positive Pressure versus Normal Pressure Technique: Before and After Observational Study
Scientific Title
Risk of Postoperative Pneumonia after Extubation with the Positive Pressure versus Normal Pressure Technique: Before and After Observational Study Using the Perioperative Database from the University of Tsukuba Hospital
Scientific Title:Acronym
Risk of Postoperative Pneumonia after Extubation with the Positive Pressure versus Normal Pressure Technique: Before and After Observational Study
Region
| Japan |
Condition
Condition
Postoperative pneumonia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to compare the risk of postoperative pneumonia after extubation with positive pressure to normal pressure technique. The Department of Anesthesiology at the University of Tsukuba Hospital had been performing a positive pressure technique for extubation after general anesthesia with endotracheal intubation. However, after the outbreak of coronavirus-19 infection, the extubation technique was changed from the positive pressure technique to a normal pressure technique in order to prevent droplet infection during extubation. Although the positive pressure technique is theoretically effective in preventing aspiration pneumonia, no human studies have confirmed its efficacy. Therefore, the purpose of this study was to compare the incidence of postoperative pneumonia between positive and normal pressure techniques.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pneumonia
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The perioperative database from the University of Tsukuba Hospital has patients who underwent surgery under general anesthesia, spinal anesthesia, or epidural anesthesia at the University of Tsukuba Hospital between April 1, 2017 and March 31, 2022.
Among them, patients who underwent surgery under general anesthesia with tracheal intubation are included.
Key exclusion criteria
Patients who underwent surgery under general anesthesia without tracheal intubation. Patients who underwent surgery under spinal or epidural anesthesia.
Those who refused to participate in the study as a result of opting out.
Target sample size
35000
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Tamiya |
Organization
University of Tsukuba
Division name
Department of Health Services Research, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tenno-dai, Tsukuba, Ibaraki, Japan
TEL
+81-(0)29-853-8849
hsr@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences
Zip code
305-8575
Address
1-1-1 Tenno-dai, Tsukuba, Ibaraki, Japan
TEL
+81-(0)29-853-8849
Homepage URL
hsr@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R03-068
Org. issuing International ID_1
University of Tsukuba Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20011
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is the before and after observational study using a perioperative database from the University of Tsukuba Hospital. The database has patients who underwent surgery under general anesthesia, spinal anesthesia, or epidural anesthesia at the University of Tsukuba Hospital between April 1, 2017 and March 31, 2022. Among them, patients who underwent surgery under general anesthesia with tracheal intubation are included.
The Department of Anesthesiology at the University of Tsukuba Hospital had been performing a positive pressure technique for extubation after general anesthesia with endotracheal intubation. However, after the outbreak of coronavirus-19 infection, the extubation technique was changed from the positive pressure technique to a normal pressure technique in order to prevent droplet infection during extubation. Although the positive pressure technique is theoretically effective in preventing aspiration pneumonia, no human studies have confirmed its efficacy. Therefore, the purpose of this study was to compare the incidence of postoperative pneumonia between positive and normal pressure techniques.
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055364
