UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Design and application of a new device to ventilate edentulous patients at Hospital Universitario Fundacion Santa Fe de Bogota
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Maria Claudia Nino
Organization	Department of Anesthesiology, Hospital Fundaci0n Santa Fe de Bogota.
Division name	Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Address	Carrera 7 No. 117-15. Bogota, Colombia
TEL	+5716030303
Email	anestesia@fsfb.org.co

Public contact
Name of contact person	Juan Carlos Diaz
Organization	Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Division name	Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Address	Carrera 7 No. 117-15. Bogota, Colombia
TEL	+5716030303
Homepage URL
Email	judiazco@gmail.com

Sponsor
Institute	Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025120