UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Acronym	Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Scientific Title	Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Scientific Title:Acronym	Comparison of Nasal pillow noninvasive positive pressure ventilation and high flow nasal therapy for the treatment and prevention of post extubation failure in intensive care patients
Region	Japan

Condition
Condition	ICU patients
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove the hypothesis that nasal pillow noninvasive positive pressure ventilation (NP-NPPV) has the same tolerability as high flow nasal therapy (HFNT) and higher respiratory support capacity than HFNT in patients after extubation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcomes were respiratory parameters (PO2/FIO2 ratio, PCO2, respiratory rate) and tolerability of each interface immediately after extubation and 24 hours later.
Key secondary outcomes	The secondary outcomes were the duration of device use, the rate of device withdrawal after 24 hours, and the incidence of skin injury associated with the interface.

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent NP-NPPV or HFNT after extubation to prevent post-extubation failure after more than 24 hours of ventilatory management after surgery
Key exclusion criteria	Non-operative patients, patients who did not require ventilatory management for more than 24 hours postoperatively, patients younger than 18 years, patients who used both NP-NPPV and HFNT, tracheostomy, head and neck surgery, significant neurological disorders, patients who used NPPV or HFNT preoperatively
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoshifumi Middle name Last name Ohchi
Organization	Oita University
Division name	Department of Anesthesiology and Intensive Care, Faculty of Medicine
Zip code	879-5593
Address	1-1 Idaigaoka, Hasamamachi, Yufu City, Oita
TEL	0975865943
Email	ohchi-yo@oita-u.ac.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Ohchi
Organization	Oita University
Division name	Department of Anesthesiology and Intensive Care, Faculty of Medicine
Zip code	879-5593
Address	1-1 Idaigaoka, Hasamamachi, Yufu City, Oita
TEL	0975865943
Homepage URL	http://anesth.wp.med.oita-u.ac.jp/research1/631
Email	ohchi-yo@oita-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Intensive Care, Faculty of Medicine, Oita University
Institute
Department

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	Oita University Faculty of Medicine Ethics Committee
Address	1-1 Idaigaoka, Hasamamachi, Yufu City, Oita
Tel	097-586-6380
Email	rinrikenkyu@oita-u.ac.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	大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://journals.sagepub.com/doi/10.1177/03000605221112777?url_ver=Z39.88-2003&rfr_id=ori:rid:crossr
Number of participants that the trial has enrolled	110
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	2019 Year 09 Month 13 Day
Date of IRB	2019 Year 09 Month 13 Day
Anticipated trial start date	2019 Year 09 Month 13 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Under the analysis of the obtained data

Management information
Registered date	2021 Year 09 Month 02 Day
Last modified on	2022 Year 09 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051788