UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029269
Receipt number R000033454
Scientific Title Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Date of disclosure of the study information 2017/09/25
Last modified on 2022/10/02 12:02:11

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Basic information

Public title

Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy

Acronym

Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy

Scientific Title

Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy

Scientific Title:Acronym

Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy

Region

Japan


Condition

Condition


Gastrointestinal disease

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

evaluating oxygen delivery to maintain the safeness of sedated patients during nasal endoscopy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

transdermal oxygen saturation duaring endoscopy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

transnasal catheterization

Interventions/Control_2

cannula

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patient who undergo endoscopy under sdation

Key exclusion criteria

Patients who have permanent tracheostoma or serious respiratory tract, otolaryngology disorder

Target sample size

116


Research contact person

Name of lead principal investigator

1st name Ken
Middle name
Last name Ishii

Organization

NTT Medical Center Tokyo

Division name

Department of Gastroenterology

Zip code

1410022

Address

5-9-22 Higashigotanda Shinagawaku Tokyo

TEL

0334486111

Email

meitokuso@yahoo.co.jp


Public contact

Name of contact person

1st name Ken
Middle name
Last name Ishii

Organization

NTT Medical Center Tokyo

Division name

Department of Gastroenterology

Zip code

1410022

Address

5-9-22 Higashigotanda Shinagawaku Tokyo

TEL

0334486111

Homepage URL


Email

meitokuso@yahoo.co.jp


Sponsor or person

Institute

NTT Medical Center Tokyo
Department of Gastroenterology

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

NTT Medical Center Tokyo

Address

5-9-22 Higashigotanda Shinagawaku Tokyo

Tel

0334486111

Email

meitokuso@yahoo.co.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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 25 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/journal/26924609

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/journal/26924609

Number of participants that the trial has enrolled

116

Results

Nasal catheterization is superior to conventional oxygen administration

Results date posted

2022 Year 10 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Adults undergoing sedation endoscopy. Nasal catheter group: 71 years old, male-female ratio: 62.1:37.9%; conventional method: 72 years old, male-female ratio: 74.1:25.9%. There was no significant difference.

Participant flow

Of the 116 patients, 58 were assigned to nasal catheterization and conventional technique.

Adverse events

No major adverse events were seen with nasal catheterization, whereas hypoxia was seen with conventional technique.

Outcome measures

Primary endpoint is the rate of desaturation, which indicated the peripheral transcutaneous oxygen saturation showed below 90% which indicated acute respiratory deterioration at any points during the procedures. Secondary concern is side its effects and safety placing single sided trans-nasal catheter or nasal catheter in each group.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 07 Month 01 Day

Date of IRB

2017 Year 06 Month 21 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded

2022 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 24 Day

Last modified on

2022 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033454


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name