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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000011925 |
Receipt No. | R000013922 |
Scientific Title | Oxygen mask with capnometry is useful for CO2 monitoring after surgery. |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2015/08/24 |
Basic information | ||
Public title | Oxygen mask with capnometry is useful for CO2 monitoring after surgery. | |
Acronym | Usefulness of oxygen mask with capnometry | |
Scientific Title | Oxygen mask with capnometry is useful for CO2 monitoring after surgery. | |
Scientific Title:Acronym | Usefulness of oxygen mask with capnometry | |
Region |
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Condition | ||
Condition | thoracic and abdominal tumor | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose is to make a study whether oxygen mask with capnometry is able to be alternative device with arterial blood gas analysis for assessment of respiratory condition after surgery. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The relationship between end tidal carbon dioxide and partial pressure of carbon dioxide in blood. After administration of oxygen as 6 liter per min , 5 liter per min and 4 liter per min for 30 mins respectively, make comparison between end tidal and blood carbon dioxide. |
Key secondary outcomes | Make comparison of dissociation between end tidal carbon dioxide and partial pressure of carbon dioxide during deep breath in oxygen administration as 6 liter per min, 5 liter per min and 4 liter per min. |
Base | |
Study type |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Rather than the normal oxygen mask, to perform the oxygen administration by oxygen mask with capnometry. | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | I intend for adult patients who are extubated in the operating room in the postoperative patient Hepatobiliary and pancreatic disease. | |||
Key exclusion criteria | I exclude patients who are state of consternation and respiratory depression due to chronic obstructive pulmonary disease and lung resection, under 18 years of age and serious injuries lung disease. | |||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Yokohama City University Hospital | ||||||
Division name | Intensive Care Unit | ||||||
Zip code | |||||||
Address | 3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan | ||||||
TEL | 045-787-2800 | ||||||
shunty5323@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Yokohama City University Hospital | ||||||
Division name | Intensive Care Unit | ||||||
Zip code | |||||||
Address | 3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan | ||||||
TEL | 0457872800 | ||||||
Homepage URL | |||||||
shunty5323@gmail.com |
Sponsor | |
Institute | Yokohama City University Hospital Department of Anesthesiology |
Institute | |
Department |
Funding Source | |
Organization | Yokohama City University Hospital Department of Anesthesiology |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 横浜市立大学附属病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://rc.rcjournal.com/content/early/2015/01/13/respcare.03557 |
Number of participants that the trial has enrolled | |
Results | Oxygen mask capnometry type may be useful for respiratory monitoring.
Absolute value of EtCO2 was widely variable, therefore it is suitable for monitoring of transition of CO2 value. |
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 | Main results already published | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Other | |
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Management information | |||||||
Registered date |
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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=R000013922 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |