UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011885 |
|---|---|
| Receipt number | R000013895 |
| Scientific Title | Prospective intervention study comparing of the effects of Neurally adjusted ventilatory assist (NAVA) and pressure support ventilaton (PSV) in patients with mechanical ventilation. |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2016/03/20 14:54:52 |
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Basic information
Public title
Prospective intervention study comparing of the effects of Neurally adjusted ventilatory assist (NAVA) and pressure support ventilaton (PSV) in patients with mechanical ventilation.
Acronym
Clinical comparison between NAVA and PSV: a prospective intervention study.
Scientific Title
Prospective intervention study comparing of the effects of Neurally adjusted ventilatory assist (NAVA) and pressure support ventilaton (PSV) in patients with mechanical ventilation.
Scientific Title:Acronym
Clinical comparison between NAVA and PSV: a prospective intervention study.
Region
| Japan |
Condition
Condition
patients with mechanical ventilation
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy between Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient-ventilator synchronization and the intensity of respiratory discomfort(Numerical Rating Scale, Dyspnea 12)
Key secondary outcomes
Blood pressure, heart rate, respiratory rate, blood gas analysis, trigger delay, work of breathing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
pressure support ventilaton (PSV) for 20 minutes, wash out for 10 minutes, and Neurally adjusted ventilatory assist (NAVA) for 20 minutes
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
1. Patients underwent mechanical ventilation for more than 24 hours.
2. Patients are conscious and ready for extubation.
3. Written informed consent of participation.
Key exclusion criteria
1. Patients with delirium.
2. Patients with any contraindication for the insertion of a nasogastric tube.
3. Other patients judged to be inappropriate at the discretion of investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Suzuki |
Organization
Tosei General Hospital
Division name
Respiratory Medicine and Allergy
Zip code
Address
60, Nishioiwake-cho, Seto, Aichi, Japan
TEL
0561-82-5101
atsushi-salyu@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Suzuki |
Organization
Tosei General Hospital
Division name
Respiratory Medicine and Allergy
Zip code
Address
160, Nishioiwake-cho, Seto, Aichi, Japan
TEL
0561-82-5101
Homepage URL
atsushi-salyu@hotmail.co.jp
Sponsor or person
Institute
Tosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
MAQUET Critical Care AB
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
公立陶生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 27 | 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
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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2016 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013895
