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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048589
Receipt No. 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 2022/08/04

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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
Email 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
Email hsr@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 27 Day
Date of IRB
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
2022 Year 08 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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