UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000014133
Receipt number	R000016417
Scientific Title	Evaluation of the PEEP effect of nasal high flow compared with non-invasive positive pressure ventilation
Date of disclosure of the study information	2014/06/01
Last modified on	2018/01/13 23:05:13

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Basic information

Public title

Evaluation of the PEEP effect of nasal high flow compared with non-invasive positive pressure ventilation

Acronym

Evaluation of the PEEP effect of nasal high flow

Scientific Title

Evaluation of the PEEP effect of nasal high flow compared with non-invasive positive pressure ventilation

Scientific Title:Acronym

Evaluation of the PEEP effect of nasal high flow

Region

Japan

Condition

Patients receiving non-invasive positive pressure ventilation for respiratory failure

Classification by specialty

Medicine in general Surgery in general

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To evaluate the PEEP effect of nasal high flow (NHF) as compared with non-invasive positive pressure ventilation (NPPV) through evaluation of respiratory parameters including blood gas analysis after weaning from NPPV to NHF

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

The difference of partial pressure of arterial oxygen tension to inspiratory oxygen fraction ratio and respiratory ratio between NHF and NPPV

Key secondary outcomes

The rate of rescue NIV therapy and intubation, the frequency of respiratory failure, the duration of NHF therapy, the length of ICU stay after weaning from NIV, and acceptability of NHF therapy compared with NIV

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

Among patients under management of NPPV for more than 24 hours, those who meet the following criteria at the 5cmH2O PEEP level; 1) 300 > P/F ratio > 200 2) 15 < respiratory rate < 30/min

Key exclusion criteria

Patients younger than 18 years old or with Glasgow Coma Scale less than 14 or with body mass index (BMI) more than 30

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Takuya Kurazumi

Organization

Kawasaki Municipal Hospital

Division name

Anesthesiology

Zip code

Address

12-1 Shinkawadori, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-0013 Japan

TEL

044-233-5521

Email

takfromnarita@yahoo.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Takeshi Suzuki

Organization

Keio University School of Medicine

Division name

Department of Anesthesiology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Homepage URL

Email

takeshi-su@a7.keio.jp

Sponsor or person

Institute

Kawasaki Municipal Hospital

Institute

Department

Personal name

Funding Source

Organization

Kawasaki Municipal Hospital

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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 01 Day

Related information

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2012 Year 08 Month 20 Day

Date of IRB

Anticipated trial start date

2012 Year 09 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

In patients who met the weaning criteria, the respiratory setting of NPPV was changed to continuous positive airway pressure (CPAP) mode with PEEP of 4 cmH2O and FIO2 equal to or less than 0.5. Blood gas analysis and evaluation of respiratory rate were performed one hour after changing the respiratory setting. Thereafter, NIV was interrupted and humidified high-flow oxygen via NHF system was delivered through a wide-bore nasal cannula at the following setting; gas flow 50 l/min and FIO2 equal to or less than 0.5. One hour after the application of NHF, blood gas analysis and evaluation of respiratory rate were performed, and compared with those during NPPV management. In the historical control group who were weaned from NPPV to oxygen mask, the same evaluation of respiratory parameters was performed.

Management information

Registered date

2014 Year 05 Month 31 Day

Last modified on

2018 Year 01 Month 13 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016417

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name