Carbon Dioxide Gas for Endoscopy in Children

Overseen By Chinenye R Dike, MD MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Chronic lung disease, ASA 4+, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

350 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Carbon Dioxide Gas for endoscopy in children?

Research shows that using carbon dioxide (CO2) instead of air during endoscopy in children can reduce post-procedure pain and bloating, as CO2 is absorbed and eliminated by the body more efficiently. Studies also indicate that CO2 insufflation is safe, with no significant adverse events reported. ^{1 2 3 4 5}

Is carbon dioxide gas safe for use in pediatric endoscopy?

Yes, using carbon dioxide gas in pediatric endoscopy is considered safe. Studies show it causes less bloating and discomfort compared to room air, and no significant adverse events were reported. ^{5 6 7 8 9}

How is carbon dioxide gas used in pediatric endoscopy different from other treatments?

Carbon dioxide gas is used instead of air during pediatric endoscopy to reduce post-procedure pain and bloating, as it is absorbed more quickly by the body and eliminated through the lungs, making it potentially more comfortable for children. ^{1 2 4 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to compare the efficacy and safety of air versus carbon dioxide gas insufflation for endoscopy in children. The main question\[s\] it aims to answer are: •to determine safety of CO2 Assess patient comfort (abdominal pain, flatulence and bloating) with CO2 use when compared to air.

Eligibility Criteria

This trial is for infants and children aged 6 months to 18 years who need an upper endoscopy procedure, such as EGD/Colonoscopy or ERCP. It's not for kids who are wards of the state, those needing non-Spanish language interpreting services, or with chronic lung disease or severe systemic illness (ASA level 4+).

Exclusion Criteria

My child has a long-term lung condition.

My child needs a non-Spanish language interpreter.

Children who are wards of the state will be excluded.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children undergo endoscopic procedures with either air or CO2 gas insufflation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Immediately after the procedure

1 visit (in-person)

Treatment Details

Interventions

• Carbon Dioxide Gas

Trial Overview The study is testing if using carbon dioxide gas during endoscopy is safer and more comfortable than air. Children will be randomly assigned to receive either CO2 or air to see which causes less abdominal pain, flatulence, and bloating.

Participant Groups

Group I: Carbondioxide Experimental Treatment 1 Intervention

Group II: Air Placebo Group 1 Intervention

Carbon Dioxide Gas is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Carbon dioxide gas for:

• Endoscopy insufflation

Approved in European Union as Carbon dioxide gas for:

• Endoscopy insufflation

Approved in Canada as Carbon dioxide gas for:

• Endoscopy insufflation

Approved in Japan as Carbon dioxide gas for:

• Endoscopy insufflation

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

In a study involving 59 children undergoing esophagogastroduodenoscopy (EGD), those receiving carbon dioxide (CO2) insufflation showed transient elevations in end-tidal CO2 (EtCO2) levels, but these were not linked to significant increases in systemic CO2 levels as measured by transcutaneous CO2 (tCO2).

The findings suggest that the elevated EtCO2 during CO2 insufflation is likely due to eructated CO2 rather than excessive systemic absorption, indicating that CO2 insufflation is safe for use in non-intubated pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient End-Tidal Carbon Dioxide Elevation During Pediatric Upper Endoscopy With Carbon Dioxide Insufflation: Is It True Hypercapnia? Dike, CR., Bishop, WP., Titler, SS., et al.[2023]

In a study of 309 patients undergoing ileo-colonoscopy and gastroscopy, using carbon dioxide (CO2) for insufflation significantly reduced abdominal pain compared to air, indicating better patient comfort post-procedure.

Patients who received CO2 insufflation also experienced less abdominal distension, as shown by a smaller increase in waist circumference after the procedures, highlighting the efficacy of CO2 in minimizing discomfort during endoscopic examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon dioxide vs. air insufflation in ileo-colonoscopy and in gastroscopy plus ileo-colonoscopy: a comparative study. Fernández-Calderón, M., Muñoz-Navas, MÁ., Carrascosa-Gil, J., et al.[2019]

In a study of 40 pediatric patients undergoing outpatient colonoscopy, those who received CO2 insufflation reported significantly lower post-procedure pain compared to those who received air insufflation, particularly at 1 and 6 hours after the procedure.

The study found that CO2 insufflation is as safe as air, with no significant differences in end tidal CO2 levels between the two groups, suggesting that CO2 is an effective option for reducing pain in pediatric colonoscopies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insufflation With Carbon Dioxide During Pediatric Colonoscopy for Control of Postprocedure Pain. Thornhill, C., Navarro, F., Alabd Alrazzak, B., et al.[2019]

In a review of five randomized controlled trials involving 450 pediatric patients, CO2 insufflation during gastrointestinal endoscopic procedures significantly reduced postoperative pain compared to air insufflation, with an odds ratio of 0.40.

There were no significant differences in abdominal distention between the two groups, and while CO2 levels were elevated in some patients, no pulmonary complications were reported, suggesting CO2 is safe for use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon Dioxide vs. Air Insufflation for Pediatric Gastrointestinal Endoscopy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ji, C., Liu, X., Huang, P.[2021]

In a study of 97 children undergoing colonoscopy, the use of carbon dioxide (CO2) instead of room air significantly reduced the incidence of abdominal bloating (P = 0.0012) and decreased the need for additional opioids for sedation (P = 0.023).

While there was only a trend towards lower post-interventional pain with CO2 (P = 0.15), the overall findings suggest that CO2 insufflation is safe and may lead to a more comfortable recovery for deeply sedated pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon dioxide versus room air for colonoscopy in deeply sedated pediatric patients: a randomized controlled trial. Kresz, A., Mayer, B., Zernickel, M., et al.[2020]

Pediatric gastrointestinal endoscopy is generally safe and effective for diagnosing and managing various gastrointestinal diseases, but certain patient factors can increase the risk of adverse events (AEs) such as bleeding, perforation, and infection.

High-risk patients, including those with congenital heart disease or compromised immune systems, require careful risk stratification and specific clinical practices, like CO2 insufflation and proper endoscopic techniques, to minimize potential complications during and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Endoscopy and High-risk Patients: A Clinical Report From the NASPGHAN Endoscopy Committee. Lightdale, JR., Liu, QY., Sahn, B., et al.[2021]

A study involving 110 COPD patients undergoing extended endoscopic procedures found that CO2 insufflation is safe, with only a slight increase in end-tidal CO2 (EtCO2) levels during and after the procedure.

The incidence of complications, such as difficulty in extubation, was low and comparable between COPD patients (2.8%) and non-COPD patients (0.9%), suggesting that CO2 insufflation does not significantly increase risks for patients with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of chronic obstructive pulmonary disease patients undergoing carbon dioxide insufflation in extended endoscopic procedures. Helgeson, SA., Lewis, KL., Carter, LE., et al.[2022]

In a pilot study involving 37 children aged 5 to 17, inhaled nitrous oxide (Entonox) was found to provide rapid and effective sedation for gastrointestinal endoscopy, with 92% of endoscopists rating the sedation efficacy as good or excellent.

The use of Entonox resulted in minimal pain scores (median of 20 for upper GI endoscopy) and allowed for quick discharge from the endoscopy suite, indicating it may be a safe and efficient alternative to traditional sedation methods, although further randomized studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrous oxide sedation in pediatric patients undergoing gastrointestinal endoscopy. Michaud, L., Gottrand, F., Ganga-Zandzou, PS., et al.[2019]

In a study involving 178 pediatric patients undergoing endoscopic procedures, the use of carbon dioxide (CO2) for insufflation did not significantly reduce abdominal discomfort or improve ease of procedure compared to air.

While CO2 was associated with less bloating and flatulence, it also caused transient spikes in end-tidal CO2 levels, raising concerns about potential systemic hypercarbia, which questions its routine use in pediatric endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Carbon Dioxide Insufflation During Endoscopy in Children as Safe and as Effective as We Think? Dike, CR., Rahhal, R., Bishop, WP.[2021]

In a study of 195 pediatric patients undergoing esophagogastroduodenoscopy (EGD), transient elevations in exhaled carbon dioxide (EtCO2) were more common with carbon dioxide (CO2) insufflation compared to air insufflation (16% vs 5%), particularly when using a laryngeal mask airway (LMA).

Despite these transient elevations in EtCO2, there were no significant changes in minute ventilation (MV) or adverse clinical effects observed, suggesting that while CO2 may reduce post-procedural flatulence, caution is warranted due to the increased risk of elevated EtCO2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elevations in End-Tidal CO 2 With CO 2 Use During Pediatric Endoscopy With Airway Protection: Is This Physiologically Significant? Dike, CR., Huang Pacheco, A., Lyden, E., et al.[2023]

In a study of 100 deeply sedated children undergoing colonoscopy, CO2 insufflation was associated with significantly lower postprocedural abdominal pain compared to air insufflation, particularly after adjusting for baseline pain factors.

CO2 insufflation also led to a decrease in abdominal circumference after the procedure, suggesting it may be a safer and more effective option for reducing discomfort during pediatric colonoscopies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Carbon Dioxide Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients. Dharmaraj, R., Dunn, R., Fritz, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transient End-Tidal Carbon Dioxide Elevation During Pediatric Upper Endoscopy With Carbon Dioxide Insufflation: Is It True Hypercapnia? [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

Carbon dioxide vs. air insufflation in ileo-colonoscopy and in gastroscopy plus ileo-colonoscopy: a comparative study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Insufflation With Carbon Dioxide During Pediatric Colonoscopy for Control of Postprocedure Pain. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Carbon Dioxide vs. Air Insufflation for Pediatric Gastrointestinal Endoscopy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Carbon dioxide versus room air for colonoscopy in deeply sedated pediatric patients: a randomized controlled trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Pediatric Endoscopy and High-risk Patients: A Clinical Report From the NASPGHAN Endoscopy Committee. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Safety of chronic obstructive pulmonary disease patients undergoing carbon dioxide insufflation in extended endoscopic procedures. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Nitrous oxide sedation in pediatric patients undergoing gastrointestinal endoscopy. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Is Carbon Dioxide Insufflation During Endoscopy in Children as Safe and as Effective as We Think? [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Elevations in End-Tidal CO 2 With CO 2 Use During Pediatric Endoscopy With Airway Protection: Is This Physiologically Significant? [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Carbon Dioxide Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients. [2021]