UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021780 |
|---|---|
| Receipt number | R000025120 |
| Scientific Title | Design and application of a new device to ventilate edentulous patients at Hospital Universitario Fundacion Santa Fe de Bogota |
| Date of disclosure of the study information | 2016/04/05 |
| Last modified on | 2016/04/05 00:33:44 |
* 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
Design and application of a new device to ventilate edentulous patients at Hospital Universitario Fundacion Santa Fe de Bogota
Acronym
A new device to ventilate the edentulous patient
Scientific Title
Design and application of a new device to ventilate edentulous patients at Hospital Universitario Fundacion Santa Fe de Bogota
Scientific Title:Acronym
A new device to ventilate the edentulous patient
Region
| South America |
Condition
Condition
A new device to ventilate edentulous patients
Classification by specialty
| Medicine in general | Surgery in general | Anesthesiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a new device to provide facemask ventilation in edentulous patients at Hospital Universitario Fundacion Santa Fe de Bogota.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy and safety of a new device (NIPARA) in facemask ventilation in edentulous patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved 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
1. NIPARA device group: patientes in this group were ventilated with the new device.
Both groups received same number of ventilations each 5 to 6 seconds (first 14 in total were evaluated) during anesthetic induction. Anesthetic induction was standardized. No neuromuscular relaxants were used.
Interventions/Control_2
2. Control group: patients in this group were ventilated withou the new device.
Both groups received same number of ventilations each 5 to 6 seconds (first 14 in total were evaluated) during anesthetic induction. Anesthetic induction was standardized. No neuromuscular relaxants were used.
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
Edentulous patients 18 years or older with a body mass index < 30 kg/m2.
Key exclusion criteria
Exclusion criteria were presence of a beard 5mm or longer, presence of mass in neck or oral cavity, patients already intubated or with tracheotomy, craniofacial malformations, oral lesions or infections, or a grade 4 in Hans scale for mask ventilation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maria Claudia Nino |
Organization
Department of Anesthesiology, Hospital Fundaci0n Santa Fe de Bogota.
Division name
Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Zip code
Address
Carrera 7 No. 117-15. Bogota, Colombia
TEL
+5716030303
anestesia@fsfb.org.co
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Juan Carlos Diaz |
Organization
Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Division name
Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Zip code
Address
Carrera 7 No. 117-15. Bogota, Colombia
TEL
+5716030303
Homepage URL
judiazco@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 05 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 04 | Month | 04 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 05 | Day |
Last modified on
| 2016 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025120
