CO2 vs Air Insufflation in Children Undergoing PEG

January 15, 2021 updated by: Tadej Battelino, University Medical Centre Ljubljana

CO2 vs Air Insufflation in Children Undergoing PEG (CO2pegA) - a Multicenter Double Blind RCT

Ap¬plications of CO2 insufflation for endoscopic procedures have been reported for the performance of routine colonoscopy, small bowel endoscopy, endoscopic retro¬grade cholangiopancreatography (ERCP) and endoscopic submucosal dissection in the upper and lower gastrointestinal tracts. These studies showed that CO2 insufflation reduces the post-procedural abdominal distension and pain without CO2 retention and adverse events. However, there has been no report on the safety and efficacy of CO2 insufflation in PEG procedures in adults or in children. In the present study, we would like to evaluate by randomized controlled trial: the safety of the CO2 insufflation during PEG and the inhibi¬tory effects of CO2 insufflation on bowel distension after PEG.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ap¬plications of CO2 insufflation for endoscopic procedures have been reported for the performance of routine colonoscopy, small bowel endoscopy, endoscopic retro¬grade cholangiopancreatography (ERCP) and endoscopic submucosal dissection in the upper and lower gastrointestinal tracts. These studies showed that CO2 insufflation reduces the post-procedural abdominal distension and pain without CO2 retention and adverse events. However, there has been no report on the safety and efficacy of CO2 insufflation in PEG procedures in adults or in children. In the present study, we would like to evaluate by randomized controlled trial: the safety of the CO2 insufflation during PEG and the inhibi¬tory effects of CO2 insufflation on bowel distension after PEG.

The primary objective is to determine the safety of the CO2 insufflation during PEG. The secondary objective of this study is to investigate the inhibitory effect of CO2 insufflation on bowel distension.

This is an investigator initiated multicentre, randomized, double blind study to evaluate the safety and adverse events profile of CO2 insufflation during PEG procedure. The study included a screening, pre-intervention (pre-PEG) and a post-intervention time (after-PEG), with total of 4 measurements of waist circumference, two measurements of i-stat.

Children aged 0-19 years, who were admitted for PEG procedure and who meet all inclusion and none of the exclusion criteria listed below. A total of 120 children after PEG insertion will be included and divided in two groups: one step group and standard pull group of children; two established groups will be randomized 1:1.

Inclusion criteria

  • Male or female patients
  • Age between 0 - 19 years
  • Written informed consent Exclusion criteria
  • Absolute contraindication for PEG procedure
  • Patients with hypercapnia (pCO2 > 50 mmHg at first i-stat measurement)
  • Language barriers which do not allow to give informed consent Patient data will be collected: age, gender, body mass index (BMI), underlining disease, duration of procedure, type of procedure, type of the scope, type of sedation or anaesthesia, complications.

Due to study protocol capillary blood will be withdrawn twice. To conclude there are actually no additional risks for included children due to the study protocol. Moreover, we will be able to diagnose early the important pneumoperitoneum, if it will occur and start to treat it with effective pain killers.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients indicated for PEG procedure
  • Age between 0 - 19 years
  • Written informed consent

Exclusion Criteria:

  • Absolute contraindication for PEG procedure
  • Patients with hypercapnia (pCO2 > 50 mmHg at first i-stat measurement)
  • Language barriers which do not allow to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single steep arm- CO2 insufflation
PEG will be performed by single step technique and CO2 will be insufflated during the endoscopy
Other: CO2
to insufflate CO2 into the stomach instead of air during the PEG
Active Comparator: Single steep arm- air insufflation
PEG will be performed by single step technique and air will be insufflated during the endoscopy
Other: air
to insufflate air into the stomach instead of CO2 during the PEG
Experimental: Pull technique arm- CO2 insufflation
PEG will be performed by pull technique and CO2 will be insufflated during the endoscopy
Other: CO2
to insufflate CO2 into the stomach instead of air during the PEG
Active Comparator: Pull technique arm- air insufflation
PEG will be performed by pull technique and air will be insufflated during the endoscopy
Other: air
to insufflate air into the stomach instead of CO2 during the PEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To asses the change in pCO2 before and after the procedure
Time Frame: Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure)
Perform i-stat measurement (capillary pCO2 value in mmHg)
Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To asses the change in waist circumference comparing CO2 and air insufflation
Time Frame: at four different time points: at time 0 (just before the procedure), 10 minutes later, 120 minutes later and 240 minutes later
Perform waist measurements at the level of umbilicus with measuring tape in cm
at four different time points: at time 0 (just before the procedure), 10 minutes later, 120 minutes later and 240 minutes later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

European Society of Pediatric Gastroenterology, Hepatology and Nutrition

Investigators

  • Principal Investigator: Matjaz Homan, PhD, Children's Hospital in Ljubljana
  • Principal Investigator: Mike Thomson, PhD, Sheffield Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2021

Primary Completion (Anticipated)

January 7, 2023

Study Completion (Anticipated)

January 7, 2023

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CO2pegA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

to use REDCap platform (gender, age, weight, BMI, type of procedure, type of anestesia, type of the endoscopy, time of PEG insertion, underlining diseases, complications, stat, waist circumference)

IPD Sharing Time Frame

after finishing the study to main investigators (2 years) for 1 months

IPD Sharing Access Criteria

principal investigators

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrostomy

Clinical Trials on CO2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe