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| Name | Class |
|---|---|
| Children's Hospital and Medical Center, Omaha, Nebraska | OTHER |
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During the course of an endoscopic procedure, air has historically been used to inflate the lumen to provide adequate visualization and allow for the endoscope to advance as necessary. In many adult centers, carbon dioxide is used for insufflation for all procedures. Many pediatric centers have started using carbon dioxide for insufflation during endoscopy based on the adult studies. Few pediatric studies have been done. This study is designed to test whether carbon dioxide is associated with any negative, post-procedural, outcomes in pediatric patients.
Luminal inflation is essential for adequate visualization and endoscope advancement during endoscopy. Although air has previously been the standard gas used, CO2 is increasing preferred in adult endoscopy centers, due to reports of decreased post-procedural abdominal discomfort compared to air. Few published studies in children demonstrated decreased abdominal discomfort with use of CO2, but safety concerns for its use in pediatric endoscopy remain.
This is a Double-blinded, prospective, randomized study of all pediatric patients undergoing procedures involving upper endoscopy in the Childrens Hospital & Medical Center. Randomization will be for patients undergoing upper endoscopy related procedures. Patients will be randomized 1:1 for air or CO2. Vital signs will be recorded before the procedure, throughout the procedure and after the procedure until fully awake. While in the procedure room, end-tidal CO2 level will be continuously recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air for luminal inflation | Active Comparator | Patients randomized into this arm will have luminal inflation using air. |
|
| Carbon Dioxide for luminal inflation | Active Comparator | Patients randomized into this arm will have luminal inflation using carbon dioxide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air | Other | Air will be used for luminal inflation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Procedures With Elevated End-tidal CO2 Levels | Compare the peak end-tidal CO2 levels (>/= 60 mmHg) observed during endoscopy in children managed with endotracheal intubation or laryngeal mask airway using CO2 versus air | Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Abdominal Pain | Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure | This will be assessed before and after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chinenye R Dike, MD | Children's Hospital & Medical Center / University of Nebraska Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital & Medical Center | Omaha | Nebraska | 68114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25480772 | Background | Steppan J, Hogue CW Jr. Cerebral and tissue oximetry. Best Pract Res Clin Anaesthesiol. 2014 Dec;28(4):429-39. doi: 10.1016/j.bpa.2014.09.002. Epub 2014 Sep 28. | |
| 26946413 | Background | ASGE Technology Committee; Lo SK, Fujii-Lau LL, Enestvedt BK, Hwang JH, Konda V, Manfredi MA, Maple JT, Murad FM, Pannala R, Woods KL, Banerjee S. The use of carbon dioxide in gastrointestinal endoscopy. Gastrointest Endosc. 2016 May;83(5):857-65. doi: 10.1016/j.gie.2016.01.046. Epub 2016 Mar 3. No abstract available. |
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1 participant who consented withdrew consent prior to randomization. Therefore, this patient did not undergo randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Air for Luminal Inflation | Patients randomized into this arm will have luminal inflation using air. Air: Air will be used for luminal inflation. |
| FG001 | Carbon Dioxide for Luminal Inflation | Patients randomized into this arm will have luminal inflation using carbon dioxide. Carbon Dioxide: Carbon dioxide will be used for luminal inflation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Population was mostly female, Caucasians and older children
| ID | Title | Description |
|---|---|---|
| BG000 | Air for Luminal Inflation | Patients randomized into this arm will have luminal inflation using air. Air: Air will be used for luminal inflation. |
| BG001 | Carbon Dioxide for Luminal Inflation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Procedures With Elevated End-tidal CO2 Levels | Compare the peak end-tidal CO2 levels (>/= 60 mmHg) observed during endoscopy in children managed with endotracheal intubation or laryngeal mask airway using CO2 versus air | Participants in this groups refers to procedures. Procedure count was used for analysis and not participant count | Posted | Count of Units | Procedures | Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours. | Procedures | Procedures |
|
Procedure duration which lasts between 1-2.5 hours
Procedure related adverse events such as bleeding and perforation Anesthesia related adverse events such as hypotension, hypertension, tachypnea
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Air for Luminal Inflation | Patients randomized into this arm will have luminal inflation using air. Air: Air will be used for luminal inflation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Anesthesia related | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chinenye Dike | University of Nebraska Medical Center | 402-955-5700 | chinenye.dike@unmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2021 | Jul 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2022 | Jul 26, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000388 | Air |
| D005740 | Gases |
| D002245 | Carbon Dioxide |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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Eligible study participants will be randomized 1:1 into two study arms; one receiving air and the other receiving carbon dioxide for luminal inflation.
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This is a double-blinded, prospective, randomized study
| Carbon Dioxide | Other | Carbon dioxide will be used for luminal inflation. |
|
|
| 26421801 | Background | Chen SW, Hui CK, Chang JJ, Lee TS, Chan SC, Chien CH, Hu CC, Lin CL, Chen LW, Liu CJ, Yen CL, Hsieh PJ, Liu CK, Su CS, Yu CY, Chien RN. Carbon dioxide insufflation during colonoscopy can significantly decrease post-interventional abdominal discomfort in deeply sedated patients: A prospective, randomized, double-blinded, controlled trial. J Gastroenterol Hepatol. 2016 Apr;31(4):808-13. doi: 10.1111/jgh.13181. |
| 19734597 | Background | Liu X, Liu D, Li J, Ou D, Zhou Z. [Safety and efficacy of carbon dioxide insufflation during colonoscopy]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2009 Aug;34(8):825-9. Chinese. |
| 25946475 | Background | Lynch I, Hayes A, Buffum MD, Conners EE. Insufflation using carbon dioxide versus room air during colonoscopy: comparison of patient comfort, recovery time, and nursing resources. Gastroenterol Nurs. 2015 May-Jun;38(3):211-7. doi: 10.1097/SGA.0000000000000109. |
| 26841319 | Background | Memon MA, Memon B, Yunus RM, Khan S. Carbon Dioxide Versus Air Insufflation for Elective Colonoscopy: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. Surg Laparosc Endosc Percutan Tech. 2016 Apr;26(2):102-16. doi: 10.1097/SLE.0000000000000243. |
| 19657610 | Background | Riss S, Akan B, Mikola B, Rieder E, Karner-Hanusch J, Dirlea D, Mittlbock M, Weiser FA. CO2 insufflation during colonoscopy decreases post-interventional pain in deeply sedated patients: a randomized controlled trial. Wien Klin Wochenschr. 2009;121(13-14):464-8. doi: 10.1007/s00508-009-1202-y. |
| 25393051 | Background | Sajid MS, Caswell J, Bhatti MI, Sains P, Baig MK, Miles WF. Carbon dioxide insufflation vs conventional air insufflation for colonoscopy: a systematic review and meta-analysis of published randomized controlled trials. Colorectal Dis. 2015 Feb;17(2):111-23. doi: 10.1111/codi.12837. |
| 22783048 | Background | Singh R, Neo EN, Nordeen N, Shanmuganathan G, Ashby A, Drummond S, Nind G, Murphy E, Luck A, Tucker G, Tam W. Carbon dioxide insufflation during colonoscopy in deeply sedated patients. World J Gastroenterol. 2012 Jul 7;18(25):3250-3. doi: 10.3748/wjg.v18.i25.3250. |
| 26363332 | Background | Homan 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. |
| 30705964 | Background | Kresz A, Mayer B, Zernickel M, Posovszky C. Carbon dioxide versus room air for colonoscopy in deeply sedated pediatric patients: a randomized controlled trial. Endosc Int Open. 2019 Feb;7(2):E290-E297. doi: 10.1055/a-0806-7060. Epub 2019 Jan 30. |
| 29210902 | Background | Thornhill C, Navarro F, Alabd Alrazzak B, Hashmi SS, DebRoy AN, Rhoads JM, Imseis E. Insufflation With Carbon Dioxide During Pediatric Colonoscopy for Control of Postprocedure Pain. J Clin Gastroenterol. 2018 Sep;52(8):715-720. doi: 10.1097/MCG.0000000000000910. |
| 26903288 | Background | Eastwood GM, Tanaka A, Bellomo R. Cerebral oxygenation in mechanically ventilated early cardiac arrest survivors: The impact of hypercapnia. Resuscitation. 2016 May;102:11-6. doi: 10.1016/j.resuscitation.2016.02.009. Epub 2016 Feb 21. |
| 28276211 | Background | Erdogan S, Oto A, Bosnak M. Reliability of cerebral oximeter in non-invasive diagnosis and follow-up of hypercapnia. Turk J Pediatr. 2016;58(4):389-394. doi: 10.24953/turkjped.2016.04.007. |
| 36821847 | Derived | Dike CR, Huang Pacheco A, Lyden E, Freestone D, Choudhry O, Bishop WP, Shukry M. Elevations in End-Tidal CO 2 With CO 2 Use During Pediatric Endoscopy With Airway Protection: Is This Physiologically Significant? J Pediatr Gastroenterol Nutr. 2023 May 1;76(5):660-666. doi: 10.1097/MPG.0000000000003748. Epub 2023 Feb 22. |
Patients randomized into this arm will have luminal inflation using carbon dioxide.
Carbon Dioxide: Carbon dioxide will be used for luminal inflation.
| BG002 | Total | Total of all reporting groups |
| Procedures |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Units | Procedures | Procedures |
|
| Ethnicity (NIH/OMB) | Count of Units | Procedures | Procedures |
|
| Race (NIH/OMB) | Count of Units | Procedures | Procedures |
|
| Region of Enrollment | Number | participants | Participants |
|
| BMI z score | This represents a scale of mean with standard deviations from the mean. For example z score of 0 is at mean. Z score of + 1 represents 1 SD from the mean and z score of -1 represents 1 SD below the mean. Z scores of > or = -1 represent malnutrition. Z | Median | Full Range | units on a scale | Participants |
|
Procedures randomized into this arm will have luminal inflation using carbon dioxide. Carbon Dioxide: Carbon dioxide will be used for luminal inflation. |
|
|
| Secondary | Number of Participants Reporting Abdominal Pain | Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure | Participant procedures randomized into air or CO2 for endoscopic insufflation. Participants reporting abdominal pain after procedure. Higher numbers are worse | Posted | Number | participants | This will be assessed before and after the procedure |
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 5 |
| 98 |
| EG001 | Carbon Dioxide for Luminal Inflation | Patients randomized into this arm will have luminal inflation using carbon dioxide. Carbon Dioxide: Carbon dioxide will be used for luminal inflation. | 0 | 102 | 0 | 102 | 5 | 102 |
| Hypertension | Vascular disorders | Anesthesia Related | Non-systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | Anesthesia Related | Non-systematic Assessment |
|
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| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |
| D007287 | Inorganic Chemicals |
| D017554 | Carbon Compounds, Inorganic |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |