UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of preoperative use of noninvasive ventilation (NIV) in patients with living donor liver transplantation
Title of the study (Brief title)	Preoperative use of noninvasive ventilation for living donor liver transplantation
Region	Japan

Condition
Condition	Living donor liver transplantation
Classification by specialty	Pneumology Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We study whether preoperative use of NIV for living donor liver transplantation may improve preoperative arterial blood gas and pulmonary function. Patients enrolled are randomly assigned to receive either standard treatment or NIV.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. arterial blood oxygen level 2. alveolar-arterial difference in partial pressure of oxygen
Key secondary outcomes	1. lung function testing (forced expiratory volume in one second (FEV1), FEV1/forced vital capacity, maximum mid-expiratory flow rate, respiratory muscle force) 2. preoperative chest X ray 3. postoperative arterial blood gas 4. postoperative pulmonary infection 5. postoperative death

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The patients receive NIV for 2 to 3 hours in the daytime. Pressure support is increased until the maximal level tolerated by the patients is reached.
Interventions/Control_2	The patients continue the current treatments.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Recipients of living donor liver transplantation. 2. Analysis of arterial blood gas reveals PaO2 as less than 60 mmHg or PaCO2 as more than 7.3 or analysis of nocturnal monitoring reveals PtCO2 more than 45 mmHg or SpO2 less than 90%.
Key exclusion criteria	1. recipients of emergency living donor liver transplantation 2. recipients of living donor liver retransplantation 3. Patients need to receive oxygen therapy or NIV therapy by analysis of arterial blood gas and nocturnal monitoring. 4. unstable asthma or mild chronic obstructive pulmonary disease (percent predicted FEV1) 5. pneumothorax within 6 months 6. patients complicated with chronic lung disease 7. patients complicated with acute infections. 8. patients received NIV
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuo Chin
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of respiratory management and sleep control medicine
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3852
Email	chink@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Satoshi Hamada
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Respiratory Medicine
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3830
Homepage URL
Email	sh1124@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of respiratory management and sleep control medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	nothing
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	京都大学病院（京都府）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 09 Month 24 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2015 Year 10 Month 31 Day
Date of closure to data entry	2015 Year 10 Month 31 Day
Date trial data considered complete	2015 Year 10 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 26 Day
Last modified on	2018 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010269