UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000028285
Receipt number	R000032384
Scientific Title	Multidisciplinary Approach by Respiratory Care Support Team for Patients Receiving Prolonged Mechanical Ventilation
Date of disclosure of the study information	2017/07/19
Last modified on	2017/07/19 17:58:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Multidisciplinary Approach by Respiratory Care Support Team for Patients Receiving Prolonged Mechanical Ventilation

Acronym

Multidisciplinary Approach by Respiratory Care Support Team

Scientific Title

Multidisciplinary Approach by Respiratory Care Support Team for Patients Receiving Prolonged Mechanical Ventilation

Scientific Title:Acronym

Multidisciplinary Approach by Respiratory Care Support Team

Region

Japan

Condition

tracheostomized patients undergoing prolonged mechanical ventilation

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The purpose of this prospective cohort study was to evaluate a multidisciplinary approach to ventilator weaning by a dedicated professional respiratory support team in tracheostomized patients undergoing prolonged mechanical ventilation.

Basic objectives2

Others

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

The primary outcome was the proportion of patients who could be completely liberated from ventilation, i.e., for 24 hours per day.

Key secondary outcomes

The secondary outcome was the proportion of patients who could be temporarily weaned, i.e., for more than 8 hours per day. The condition of the tracheostomy and the patient`s overall health status at the time of discharge from hospital were also assessed.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

The study participants were tracheostomized patients who had received prolonged mechanical ventilation in the intensive care unit (ICU) and were then transferred to a general ward.

Key exclusion criteria

Best support care

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Jun Hirasawa

Organization

Tosei General Hospital

Division name

Department of Rehabilitation

Zip code

Address

160 Nishioiwake-cho, Seto, Aichi 489-8642, Japan

TEL

0561-82-5101

Email

heijunjun@yahoo.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Shinichi Arizono

Organization

Seirei Christopher University,

Division name

School of Health Sciences

Zip code

Address

3453 Mikataha Kitaku, Hamamatsu, Shizuoka

TEL

053-439-1400

Homepage URL

Email

arizono-s@umin.ac.jp

Sponsor or person

Institute

Seirei Christopher University

Institute

Department

Personal name

Funding Source

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

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

2017 Year 07 Month 19 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Thirty-six (90%) of the 40 patients were successfully liberated from mechanical ventilation after a mean ventilated duration of 92.2 days.

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

2008 Year 11 Month 01 Day

Date of IRB

Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2013 Year 12 Month 31 Day

Other

Other related information

Of the remaining four patients, two were liberated from mechanical ventilation for 8 hours per day and the other two were deemed to be permanently ventilator-dependent. Of the 36 patients who were successfully weaned, 17 were discharged to home without care, four were discharged to home with care, and 13 were discharged to a nursing home. No serious problems were encountered by the RST when weaning patients from mechanical ventilation.

Management information

Registered date

2017 Year 07 Month 19 Day

Last modified on

2017 Year 07 Month 19 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032384

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name