CO2 vs Air Insufflation in Children Undergoing PEG
1 other identifier
interventional
120
7 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2021
CompletedFirst Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2023
CompletedJanuary 19, 2021
January 1, 2021
2 years
January 12, 2021
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To asses the change in pCO2 before and after the 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 Outcomes (1)
To asses the change in waist circumference comparing CO2 and air insufflation
at four different time points: at time 0 (just before the procedure), 10 minutes later, 120 minutes later and 240 minutes later
Study Arms (4)
Single steep arm- CO2 insufflation
EXPERIMENTALPEG will be performed by single step technique and CO2 will be insufflated during the endoscopy
Single steep arm- air insufflation
ACTIVE COMPARATORPEG will be performed by single step technique and air will be insufflated during the endoscopy
Pull technique arm- CO2 insufflation
EXPERIMENTALPEG will be performed by pull technique and CO2 will be insufflated during the endoscopy
Pull technique arm- air insufflation
ACTIVE COMPARATORPEG will be performed by pull technique and air will be insufflated during the endoscopy
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients indicated for PEG procedure
- Age between 0 - 19 years
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Paediatric Gastroenterology-Hepatology, Queen Fabiola Children's University Hospital
Brussels, Belgium
Children's Hospital Zagreb
Zagreb, Croatia
Policlinico Universitario Messina
Messina, Italy
University Children's Hospital
Ljubljana, 1000, Slovenia
University Children's Hospital Basel
Basel, Switzerland
Al Jalila Children's Specialty Hospital
Dubai, United Arab Emirates
Sheffield Children's Hospital
Sheffield, United Kingdom
Related Publications (4)
Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.
PMID: 6780678RESULTThomson M, Rao P, Rawat D, Wenzl TG. Percutaneous endoscopic gastrostomy and gastro-oesophageal reflux in neurologically impaired children. World J Gastroenterol. 2011 Jan 14;17(2):191-6. doi: 10.3748/wjg.v17.i2.191.
PMID: 21245991RESULTHoman M, Mahkovic D, Orel R, Mamula P. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):993-7. doi: 10.1016/j.gie.2015.08.073. Epub 2015 Sep 10.
PMID: 26363332RESULTMaple JT, Keswani RN, Hovis RM, Saddedin EZ, Jonnalagadda S, Azar RR, Hagen C, Thompson DM, Waldbaum L, Edmundowicz SA. Carbon dioxide insufflation during ERCP for reduction of postprocedure pain: a randomized, double-blind, controlled trial. Gastrointest Endosc. 2009 Aug;70(2):278-83. doi: 10.1016/j.gie.2008.12.050. Epub 2009 Jun 11.
PMID: 19523621RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matjaz Homan, PhD
Children's Hospital in Ljubljana
- PRINCIPAL INVESTIGATOR
Mike Thomson, PhD
Sheffield Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 19, 2021
Study Start
January 7, 2021
Primary Completion
January 7, 2023
Study Completion
January 7, 2023
Last Updated
January 19, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- after finishing the study to main investigators (2 years) for 1 months
- Access Criteria
- principal investigators
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)