Revisions for Insufflation with CO2 versus room air in colonoscopy | Registro Público Cubano de Ensayos Clínicos

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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)

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

Link to the spanish version:

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28 July 2016 - 8:59am by CNCMA		28 July 2016 - 9:00am by CNCMA
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Insufflation with CO2 versus room air in colonoscopy

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