CO2 vs Air Insufflation in Children Undergoing PEG

Gastrostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714021
• Other study ID #: CO2pegA
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: January 7, 2023

Study information

• Verified date: January 2021
• Source: University Medical Centre Ljubljana
• Contact: Matjaz Homan, PhD
• Phone: 0038640885848
• Email: matjaz.homan[@]guest.arnes.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 7, 2023
• Est. primary completion date: January 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrostomy

Intervention

Other:
• CO2
to insufflate CO2 into the stomach instead of air during the PEG
• air
to insufflate air into the stomach instead of CO2 during the PEG

Locations

Country	Name	City	State
Belgium	Paediatric Gastroenterology-Hepatology, Queen Fabiola Children's University Hospital	Brussel
Croatia	Children's Hospital Zagreb	Zagreb
Italy	Policlinico Universitario Messina	Messina
Slovenia	University Children's Hospital	Ljubljana
Switzerland	University Children's Hospital Basel	Basel
United Arab Emirates	Al Jalila Children's Specialty Hospital	Dubai
United Kingdom	Sheffield Children's Hospital	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	European Society of Pediatric Gastroenterology, Hepatology and Nutrition

Countries where clinical trial is conducted

Belgium,  Croatia,  Italy,  Slovenia,  Switzerland,  United Arab Emirates,  United Kingdom, 

References & 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. — View Citation

Homan 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. — View Citation

Maple 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 — View Citation

Thomson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To asses the change in waist circumference comparing CO2 and air insufflation	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