CO2 vs Air Insufflation in Children Undergoing PEG

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastrostomy

Intervention / Treatment
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* Other: CO2
* Other: air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single step PEG technique group divided to co2 or air insufflation group during endoscopy pull technique PEG group divided to co2 or air insufflation group during endoscopy
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, endoscopy, CO2 insufflation