UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the PEEP effect of nasal high flow compared with non-invasive positive pressure ventilation
Title of the study (Brief title)	Evaluation of the PEEP effect of nasal high flow
Region	Japan

Condition
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	NO

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	20

Research contact person
Name of lead principal investigator	Takuya Kurazumi
Organization	Kawasaki Municipal Hospital
Division name	Anesthesiology
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	Takeshi Suzuki
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	takeshi-su@a7.keio.jp

Sponsor
Institute	Kawasaki Municipal Hospital
Institute
Department

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)

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 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016417