UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015394
Receipt number R000017905
Scientific Title Research on the respiration status in cancer patients with sedatives and analgesics
Date of disclosure of the study information 2014/10/10
Last modified on 2014/10/09 19:59:01

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Basic information

Public title

Research on the respiration status in cancer patients with sedatives and analgesics

Acronym

Research on the respiration status in cancer patients with sedatives and analgesics

Scientific Title

Research on the respiration status in cancer patients with sedatives and analgesics

Scientific Title:Acronym

Research on the respiration status in cancer patients with sedatives and analgesics

Region

Japan


Condition

Condition

Cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To reveal the problematic respiratory status in cancer patients with sedatives and analgesics.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Number of respiratory event with SpO2<=90 per hour

Key secondary outcomes

Highest ETCO2
Respiratory rate per minute
Number of apnea per minute
Number of hypopnea per minute
Conscious level
Assessment of patient's respiratory status by medical staff


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Cancer patients who are expected to need sedatives and analgesics
2.Age>=20
3. Written informed consent
4.Fluent in Japanese
5.Hospitalized

Key exclusion criteria

1.Difficulty with attaching monitors
2.Within 7 days of operation
3.With respirator
4.Considered ineligible

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Natsuko Taguchi

Organization

Chiba University Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohanacho, Chuo-ku, Chiba 260-8670, Japan

TEL

043-226-2155

Email

nnoztag@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Natsuko Taguchi

Organization

Chiba University Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohanacho, Chuo-ku, Chiba 260-8670, Japan

TEL

043-226-2155

Homepage URL


Email

nnoztag@faculty.chiba-u.jp


Sponsor or person

Institute

Department of Anesthesiology, Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Sosiety for thr Promotion of science(JSPS)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 10 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

2014 Year 07 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Preinitiation


Management information

Registered date

2014 Year 10 Month 09 Day

Last modified on

2014 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017905


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name