GastrostomyNCT04714021
CO2 vs Air Insufflation in Children Undergoing PEG
A study testing CO2 and air in people with Gastrostomy, run by University Medical Centre Ljubljana at 7 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Gastrostomy
- What is being tested?
- CO2 and air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 7 Jan 2021to 7 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients indicated for PEG procedure
- Age between 0 - 19 years
- Written informed consent
Who cannot join
- 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 locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Belgium1 site, 1 recruiting
- Not yet recruiting
Paediatric Gastroenterology-Hepatology, Queen Fabiola Children's University Hospital
Brussels
Patrick Bontems, +32479624095, patrick.bontems@me.com
Croatia1 site, 1 recruiting
- Not yet recruiting
Children's Hospital Zagreb
Zagreb
Iva Hojsak, +385914600342, ivahojsak@gmail.com
Italy1 site, 1 recruiting
- Not yet recruiting
Policlinico Universitario Messina
Messina
Claudio Romano, romanoc@unime.it
Valeria Dipasquale, dipasquale.valeria@libero.it
Slovenia1 site, 1 recruiting
- Recruiting
University Children's Hospital
Ljubljana, 1000
Matjaz Homan, PhD, matjaz.homan@guest.arnes.si
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Children's Hospital Basel
Basel
Raoul Furlano, +41 79 469 60 69, raoul.furlano@ukbb.ch
United Arab Emirates1 site, 1 recruiting
- Not yet recruiting
Al Jalila Children's Specialty Hospital
Dubai
Christis Tzivinikos, 00971502148450, christos.tzivinikos@ajch.ae
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Sheffield Children's Hospital
Sheffield
Mike Thomson, 44 0114 271 7000, mthomson221168@gmail.com
Zuzana Londt, zuzana.londt1@nhs.net
About this study
Official title: CO2 vs Air Insufflation in Children Undergoing PEG (CO2pegA) - a Multicenter Double Blind RCT
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.
Read the 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.
- Conditions
- Gastrostomy
- Being tested
- CO2, air
- Keywords
- children, endoscopy, CO2 insufflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2Other
to insufflate CO2 into the stomach instead of air during the PEG
airOther
to insufflate air into the stomach instead of CO2 during the PEG
| Study group | Role | What they receive |
|---|---|---|
| Single steep arm- CO2 insufflation | Experimental | PEG will be performed by single step technique and CO2 will be insufflated during the endoscopy Receives: Other: CO2 |
| Single steep arm- air insufflation | Active comparator | PEG will be performed by single step technique and air will be insufflated during the endoscopy Receives: Other: air |
| Pull technique arm- CO2 insufflation | Experimental | PEG will be performed by pull technique and CO2 will be insufflated during the endoscopy Receives: Other: CO2 |
| Pull technique arm- air insufflation | Active comparator | PEG will be performed by pull technique and air will be insufflated during the endoscopy Receives: Other: air |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the change in pCO2 before and after the procedure
Perform i-stat measurement (capillary pCO2 value in mmHg)
Measured: Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure)
Secondary outcomes (1)
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
Measured: at four different time points: at time 0 (just before the procedure), 10 minutes later, 120 minutes later and 240 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start7 Jan 2021
- Primary completion7 Jan 2023 (estimated)
- Study completion7 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Responsible party
- Principal investigator, Tadej Battelino, University Medical Centre Ljubljana
- Investigators
- Matjaz Homan, PhD, Principal investigator, Children's Hospital in LjubljanaMike Thomson, PhD, Principal investigator, Sheffield Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714021
- Sponsor's protocol ID
- CO2pegA
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: to use REDCap platform (gender, age, weight, BMI, type of procedure, type of anestesia, type of the endoscopy, time of PEG insertion, underlining diseases, complications, stat, waist circumference)
Publications
Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.
PubMed 6780678Thomson 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.
PubMed 21245991Homan 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.
PubMed 26363332Maple 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 Endosc. 2009 Aug;70(2):278-83. doi: 10.1016/j.gie.2008.12.050. Epub 2009 Jun 11.
PubMed 19523621
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 vs Air Insufflation in Children Undergoing PEG (CO2pegA) - a Multicenter Double Blind RCT
- ClinicalTrials.gov ID
- NCT04714021
- Acronym / sponsor ID
- CO2pegA
- Conditions
- Gastrostomy
- Keywords
- children, endoscopy, CO2 insufflation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- European Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 7 Jan 2023 (estimated)
- Study completion
- 7 Jan 2023 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Single steep arm- CO2 insufflation | Experimental | Other: CO2PEG will be performed by single step technique and CO2 will be insufflated during the endoscopy |
| Single steep arm- air insufflation | Active comparator | Other: airPEG will be performed by single step technique and air will be insufflated during the endoscopy |
| Pull technique arm- CO2 insufflation | Experimental | Other: CO2PEG will be performed by pull technique and CO2 will be insufflated during the endoscopy |
| Pull technique arm- air insufflation | Active comparator | Other: airPEG will be performed by pull technique and air will be insufflated during the endoscopy |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female patients indicated for PEG procedure
- Age between 0 - 19 years
- Written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2to insufflate CO2 into the stomach instead of air during the PEG | Other | Pull technique arm- CO2 insufflation, Single steep arm- CO2 insufflation |
| airto insufflate air into the stomach instead of CO2 during the PEG | Other | Pull technique arm- air insufflation, Single steep arm- air insufflation |
Primary outcome
To asses the change in pCO2 before and after the procedure
Time frame: Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure)
Perform i-stat measurement (capillary pCO2 value in mmHg)
1 secondary outcome
To asses the change in waist circumference comparing CO2 and air insufflation
Time frame: at four different time points: at time 0 (just before the procedure), 10 minutes later, 120 minutes later and 240 minutes later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Results publication: PubMed 6780678Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.
- Results publication: PubMed 21245991Thomson 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.
- Results publication: PubMed 26363332Homan 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.
- Results publication: PubMed 19523621Maple 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 Endosc. 2009 Aug;70(2):278-83. doi: 10.1016/j.gie.2008.12.050. Epub 2009 Jun 11.
- Individual participant dataSharing planned: Yes. to use REDCap platform (gender, age, weight, BMI, type of procedure, type of anestesia, type of the endoscopy, time of PEG insertion, underlining diseases, complications, stat, waist circumference)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matjaz Homan, PhD principal investigator
Children's Hospital in Ljubljana
Mike Thomson, PhD principal investigator
Sheffield Children's Hospital
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 and air in people with Gastrostomy, run by University Medical Centre Ljubljana at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Croatia, Italy, Slovenia, Switzerland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matjaz Homan, PhD (0038640885848, matjaz.homan@guest.arnes.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses the change in pCO2 before and after the procedure (time frame: Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714021, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.