CO2 vs Air Insufflation in Children Undergoing PEG
- Conditions
- Gastrostomy
- Interventions
- Other: CO2Other: air
- Registration Number
- NCT04714021
- Lead Sponsor
- University Medical Centre Ljubljana
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Male or female patients indicated for PEG procedure
- Age between 0 - 19 years
- Written informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single steep arm- CO2 insufflation CO2 PEG will be performed by single step technique and CO2 will be insufflated during the endoscopy Pull technique arm- CO2 insufflation CO2 PEG will be performed by pull technique and CO2 will be insufflated during the endoscopy Pull technique arm- air insufflation air PEG will be performed by pull technique and air will be insufflated during the endoscopy Single steep arm- air insufflation air PEG will be performed by single step technique and air will be insufflated during the endoscopy
- Primary Outcome Measures
Name Time Method To asses the change in pCO2 before and after the procedure Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure) Perform i-stat measurement (capillary pCO2 value in mmHg)
- Secondary Outcome Measures
Name Time Method 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 Perform waist measurements at the level of umbilicus with measuring tape in cm
Trial Locations
- Locations (7)
University Children's Hospital
🇸🇮Ljubljana, Slovenia
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
Al Jalila Children's Specialty Hospital
🇦🇪Dubai, United Arab Emirates
Children's Hospital Zagreb
🇭🇷Zagreb, Croatia
Paediatric Gastroenterology-Hepatology, Queen Fabiola Children's University Hospital
🇧🇪Brussel, Belgium
University Children's Hospital Basel
🇨🇭Basel, Switzerland
Policlinico Universitario Messina
🇮🇹Messina, Italy