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Insufflation with CO2 versus room air in colonoscopy
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28 July 2016 - 9:00am
by CNCMA
28 July 2016 - 9:00am
by CNCMA
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Revision of 28 July 2016 - 9:00am:
Insufflation with CO2 versus room air in colonoscopy
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
ICOC
Scientific title:
Carbon dioxide insufflation colonoscopy. Randomized controlled trial and double blind.
Acronym of Scientific Title:
ICOC
Secondary indentifying numbers:
CNCMA 4
Issuing authority of the secondary identifying numbers:
National Centre for Minimal Access Surgery (CNCMA)
Primary sponsor:
National Centre for Minimal Access Surgery (CNCMA)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Cuban Ministry of Public Health (MINSAP)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Osvaldo
Midle name:
Raiko
Last name:
Seijas Cabrera
Medical Specialty :
first-degree specialist in Gastroenterology
Affiliation:
National Centre for Minimal Access Surgery
Postal address:
Párraga e/ San Mariano y Vista Alegre. La Víbora. 10 de Octubre.
City:
La Habana.
Country:
Cuba.
Zip Code:
10700
Telephone:
+53-76495328
+53-76495332
Email address:
seijascabrera@infomed.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Research ethics committees:
National Centre for Minimal Access Surgery (CNCMA), October 1, 2013
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
13/10/2014
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Patients indicated for Colonoscopy
Intervention(s):
Expermiental Group (CO2): Colonoscopy is performed by blowing CO 2 Control Group (Placebo): Colonoscopy is performed by blowing ambient air.
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Pain (Visual Analogue Scale). Measuring time: 15 minutes, 1 hour after procedure.
Key secondary outcomes:
Number of Propofol ( Total amount of anesthetic was required) Measuring time: After procedure. Total Time (Time elapsed since the start of colonoscopy until completion the procedure) Measuring time: After procedure. CO2 pressure ( Value of measuring CO2 in the patient ) Measuring time: before, during and after procedure. O2 Saturation( Value of measuring O2 presented by the patient) Measuring time: before, during and after procedure. Heart rate (number of heartbeats in the patient) Measuring time: before, during and pafter procedure. Complications (Presence of complications due to come) Measuring time: during and after procedure.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
None
Inclusion criteria:
Male and female patients with 18 or more years old
Exclusion criteria:
1. Severe respiratory illness (hospitalization in the last 6 months or home oxygen therapy), 2. Sleep Apnea. 3. Morbid obesity. (BMI ≥ 35) 4. Inability to understand the study. 5. Performing on the day of upper endoscopy and colonoscopy. 6. Making sigmoidoscopy 7. Patients who refuse consent for participation in the study.
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Other
Other purpose:
Diagnostic and treatment
Allocation:
Randomized controlled trial
Masking:
Double Blind
Control group:
Placebo
Study design:
Parallel
Phase:
2
Target sample size:
100
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Osvaldo
Middle Name:
Raiko
Last Name:
Seijas Cabrera
Specialty:
first-degree specialist in Gastroenterology
Affiliation:
National Centre for Minimal Access Surgery (CNCMA)
Postal Address:
Parraga Street e/ San Mariano y Vista Alegre. La Vibora. 10 de Octubre.
City:
Havana
Country:
Cuba
Zip Code:
10700
Telephone:
53 (7) 649-5328, 649-5331
Email :
seijascabrera@infomed.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Osvaldo
Middle Name:
Raiko
Last Name:
Seijas Cabrera
Specialty:
first-degree specialist in Gastroenterology
Affiliation:
National Centre for Minimal Access Surgery ( CNCMA)
Postal Address:
Parraga Street e/ San Mariano y Vista Alegre. La Vibora. 10 de Octubre.
City:
Havana
Country:
Cuba
Zip Code:
10700
Telephone:
53 (7) 649-5328, 649-5331
Email :
seijascabrera@infomed.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000186
Date of Registration in Primary Registry:
09/10/2014
Record Verification Date:
2016/07/28
Next update date:
2017/07/28
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