UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033022
Receipt number R000037645
Scientific Title Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure
Date of disclosure of the study information 2018/06/20
Last modified on 2023/06/20 11:34:22

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Basic information

Public title

Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure

Acronym

Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure

Scientific Title

Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure

Scientific Title:Acronym

Effects of nneurally adjusted ventilatory assist on muscle fatigue in acute respiratory failure

Region

Japan


Condition

Condition

Acute respiratory failure

Classification by specialty

Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effects of neurally adjusted ventilatory assist on respiratory muscle fatigue in acute respiratoy failure

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

diaphragm function

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

neurally adjusted ventilatory assist

Interventions/Control_2

pressure support ventilation

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

patients with acute respiratory failure

Key exclusion criteria

1) Patients' refusal to participate in clinical research

2) General contraindications for gastric tube placement

Target sample size

50


Research contact person

Name of lead principal investigator

1st name NAOYUKI
Middle name
Last name FUJIMURA

Organization

St. Mary's Hospital

Division name

Department of Anesthesiology

Zip code

8308543

Address

422 Tsubukuhonmachi Kurume, Fukuoka

TEL

0942-35-3322

Email

n-fujimura@st-mary-med.or.jp


Public contact

Name of contact person

1st name NAOYUKI
Middle name
Last name FUJIMURA

Organization

St. Mary's Hospital

Division name

Department of Anesthesiology

Zip code

8308543

Address

422 Tsubukuhonmachi Kurume, Fukuoka

TEL

0942-35-3322

Homepage URL


Email

n-fujimura@st-mary-med.or.jp


Sponsor or person

Institute

St. Mary's Hospital

Institute

Department

Personal name



Funding Source

Organization

St. Mary's Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Mary's Hospital Our Lady of the Snow Social Medical Corporation

Address

422 Tsubukuhonmachi, Kurume, Fukuoka

Tel

0942-35-332

Email

n-fujimura@st-mary-med.or.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

13-1003

Org. issuing International ID_1

St. Mary's Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially 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

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB

2013 Year 10 Month 29 Day

Anticipated trial start date

2013 Year 10 Month 29 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 16 Day

Last modified on

2023 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037645


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name