CO2 vs Air Insufflation in Children Undergoing PEG

University Medical Centre Ljubljana

Status: Unknown

Conditions: Gastrostomy

Treatments: Other: CO2; Other: air

Study type: Interventional

Funder types: Other

Identifiers

NCT04714021

CO2pegA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Single steep arm- CO2 insufflation

Experimental group

Description:

PEG will be performed by single step technique and CO2 will be insufflated during the endoscopy

Treatment:

Other: CO2

Single steep arm- air insufflation

Active Comparator group

Description:

PEG will be performed by single step technique and air will be insufflated during the endoscopy

Treatment:

Other: air

Pull technique arm- CO2 insufflation

Experimental group

Description:

PEG will be performed by pull technique and CO2 will be insufflated during the endoscopy

Treatment:

Other: CO2

Pull technique arm- air insufflation

Active Comparator group

Description:

PEG will be performed by pull technique and air will be insufflated during the endoscopy

Treatment:

Other: air