CO2 vs Air Insufflation in Children Undergoing PEG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2023-01-07

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.

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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.

Conditions

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Gastrostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* 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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single steep arm- CO2 insufflation

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

Group Type EXPERIMENTAL

CO2

Intervention Type OTHER

to insufflate CO2 into the stomach instead of air during the PEG

Single steep arm- air insufflation

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

Group Type ACTIVE_COMPARATOR

air

Intervention Type OTHER

to insufflate air into the stomach instead of CO2 during the PEG

Pull technique arm- CO2 insufflation

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

Group Type EXPERIMENTAL

CO2

Intervention Type OTHER

to insufflate CO2 into the stomach instead of air during the PEG

Pull technique arm- air insufflation

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

Group Type ACTIVE_COMPARATOR

air

Intervention Type OTHER

to insufflate air into the stomach instead of CO2 during the PEG

Interventions

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CO2

to insufflate CO2 into the stomach instead of air during the PEG

Intervention Type OTHER

air

to insufflate air into the stomach instead of CO2 during the PEG

Intervention Type OTHER

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

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Tadej Battelino

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matjaz Homan, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital in Ljubljana

Mike Thomson, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Children's Hospital

Locations

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