UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019238
Receipt number R000022236
Scientific Title The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study
Date of disclosure of the study information 2015/10/05
Last modified on 2019/07/15 14:28:02

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Basic information

Public title

The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study

Acronym

Prospective randomized controlled study of Nasal High-flow Oxygen Therapy

Scientific Title

The comparison nasal high-flow oxygen therapy with large volume nebulization-based humidifier for patients after the extubation: randomized controlled study

Scientific Title:Acronym

Prospective randomized controlled study of Nasal High-flow Oxygen Therapy

Region

Japan


Condition

Condition

Respitratory failure after extubation

Classification by specialty

Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy of nasal high-flow oxygen therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Re-intubation rate within a week

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

nasal high-flow oxygen therapy

Interventions/Control_2

large volume nebulization-based humidifier

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Obtained a written informed consent
2. Patients received a mechanical ventilation for more than 24 hours
3. Patients who are admitted to the emergency department or ICU, and underwent a management of the mechanical ventilation and oxygen therapy by the stuff of the emergency department.
4. Patients who received extubation within 14 days after obtained the written informed consent
5. Patients with PaO2/FIO2 < 300 within 3 hours before extubation.

Key exclusion criteria

1.Patients with severe facial injury
2.Pregnancy
3.Patients with tracheostomy
4.Patients who had pneumothorax without thoracic drainage
5.Patients advocate 'Do-not-intubate status' before included this study.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Akiyoshi
Middle name
Last name Hagiwara

Organization

National Center for Global Health and Medicine

Division name

Emergency department

Zip code

162-8655

Address

Toyama 1-21-1, shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

wmatsuda@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name Wataru
Middle name
Last name Matsuda

Organization

National Center for Global Health and Medicine

Division name

Emergency department

Zip code

162-0055

Address

Toyama 1-21-1, shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

wmatsuda@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

National Center for Global Health and Medicine

Address

1-21-1, Toyama, Shinjuku-ku, Tokyo

Tel

09076476900

Email

wmatsuda@hosp.ncgm.go.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

2015 Year 10 Month 05 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

72

Results

A total of 72 patients were enrolled in this study between August 2015 and March 2018. We analyzed 69 subjects, 30 in the intervention group and 39 in the control group. Baseline characteristics were similar between the two groups.
The reintubation rate within 7 days did not differ significantly between the two groups (intervention group 5/30 subjects [17%] vs control group 6/39 subjects [15%]).

Results date posted

2019 Year 07 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Baseline characteristics were similar between the two groups. Mean age was 76 years and the main cause of respiratory failure was pneumonia (56%).

Participant flow

A total of 72 patients were enrolled in this study between August 2015 and March 2018. We analyzed 69 subjects, 30 in the intervention group and 39 in the control group.

Adverse events

One severe adverse event was detected in the intervention group, where cardiac arrest due to airway obstruction by mucous plug occurred after protocol treatment.

Outcome measures

The reintubation rate within 7 days after extubation (primary endpoint): intervention group 5/30 (17%), control group 6/39 (15%), odds ratio 1.10 (0.24-4.88)
The reintubation rate within 48 hours after extubation: intervention group 2/30 (7%), control group 5/39 (13%), odds ratio 0.49 (0.04-3.28)
The rate of reintubation or non-invasive ventilation use within 48 hours after extubation:intervention group 2/30 (7%), control group 8/39 (21%), odds ratio 0.28 (0.03-1.58)
PaO2 / FIO2set ratio within 24 hours after extubation: intervention group mean 264 mmHg, control group mean 224 mmHg
Reason for reintubation: sputum obstruction was most (intervention group 2/30 (7%), control group 3/39 (8%))
Length of oxygen therapy: intervention group mean 5.6 days, control group maen 5.9 days
Length of ICU stay: intervention group mean 4.4 days, control group mean 3.8 days
discomfort of each devices: no significant difference in either group at 1, 6, 24 or 48 hours after extubation

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 07 Month 28 Day

Date of IRB

2015 Year 07 Month 21 Day

Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 01 Day

Date analysis concluded

2019 Year 04 Month 08 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 05 Day

Last modified on

2019 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name