Trial Outcomes & Findings for Safety and Efficacy of CO2 for Endoscopy (NCT NCT03287687)

NCT ID: NCT03287687

Last Updated: 2022-01-19

Results Overview

Change in abdominal girth from baseline to end of procedure (Time Difference 1) or Change in abdominal girth from baseline to time of discharge ((Time Difference 2)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: Mean change in abdominal girth between time points were compared between groups
• Results posted on: 2022-01-19

Participant Flow

180 procedures were enrolled; 91 procedures in the CO2 group and 89 procedures in the air group. There were 178 participants enrolled. 2 participants were enrolled twice

There were no significant events in this study. There were 178 patients enrolled for 180 procedures. 2 participants were enrolled twice

Unit of analysis: Procedures

Participant milestones

Measure	Air for Insufflation In this arm of patients, air which is currently used as standard of care will be used for insufflation Air: Air is the standard of practice and will be used in the control arm	Carbon Dioxide Gas for Insufflation in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air
Overall Study STARTED	88 89	90 91
Overall Study Procedures	88 89	90 91
Overall Study COMPLETED	88 89	90 91
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Air for Insufflation n=88 Participants In this arm of patients, air which is currently used as standard of care will be used for insufflation Air: Air is the standard of practice and will be used in the control arm	Carbon Dioxide Gas for Insufflation n=90 Participants in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air	Total n=178 Participants Total of all reporting groups
Type of procedure Other	9 Participants n=88 Participants	14 Participants n=90 Participants	23 Participants n=178 Participants
Age, Customized < 4 years	2 participants n=88 Participants	6 participants n=90 Participants	8 participants n=178 Participants
Age, Customized > 4 years	86 participants n=88 Participants	84 participants n=90 Participants	170 participants n=178 Participants
Sex: Female, Male Female	53 Participants n=88 Participants	46 Participants n=90 Participants	99 Participants n=178 Participants
Sex: Female, Male Male	35 Participants n=88 Participants	44 Participants n=90 Participants	79 Participants n=178 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	88 participants n=88 Participants	90 participants n=90 Participants	178 participants n=178 Participants
Weight	47.2 kilograms n=88 Participants	46.6 kilograms n=90 Participants	46.9 kilograms n=178 Participants
ASA class status Low ASA class (I&II, low sedation risk)	55 participants n=88 Participants	65 participants n=90 Participants	120 participants n=178 Participants
ASA class status High ASA class (> II high sedation risk)	33 participants n=88 Participants	25 participants n=90 Participants	58 participants n=178 Participants
Type of procedure EGD only	44 Participants n=88 Participants	44 Participants n=90 Participants	88 Participants n=178 Participants
Type of procedure EGD/Colonoscopy	30 Participants n=88 Participants	30 Participants n=90 Participants	60 Participants n=178 Participants
Type of procedure Any Colonoscopy	36 Participants n=88 Participants	33 Participants n=90 Participants	69 Participants n=178 Participants

PRIMARY outcome

Timeframe: Mean change in abdominal girth between time points were compared between groups

Population: 178 participants were enrolled for 180 procedures

Change in abdominal girth from baseline to end of procedure (Time Difference 1) or Change in abdominal girth from baseline to time of discharge ((Time Difference 2)

Outcome measures

Measure	Air for Insufflation n=89 Procedures In this arm of patients, air which is currently used as standard of care will be used for insufflation Air: Air is the standard of practice and will be used in the control arm	Carbon Dioxide Gas for Insufflation n=91 Procedures in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air
Change in Abdominal Distension Time Difference 1: Difference from baseline to end of procedure (median 16 minutes), cm	0.9 cm Standard Deviation 2.3	0.5 cm Standard Deviation 2.0
Change in Abdominal Distension Time Difference 2: Difference from baseline to discharge (approximately 120 minutes), cm	1.1 cm Standard Deviation 2.2	0.9 cm Standard Deviation 2.5

SECONDARY outcome

Timeframe: Time frame of monitoring from start to end of procedure (average of 12 minutes for EGD procedures)

Population: 178 participants were included in 180 procedures

Number of Procedures with Elevated End Tidal CO2 level (≥ 60 mmHg)

Outcome measures

Measure	Air for Insufflation n=89 Procedures In this arm of patients, air which is currently used as standard of care will be used for insufflation Air: Air is the standard of practice and will be used in the control arm	Carbon Dioxide Gas for Insufflation n=91 Procedures in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air
Elevations of End Tidal Carbon Dioxide	5 Procedures	34 Procedures

SECONDARY outcome

Timeframe: Frequency of reported symptoms up to 4 hours post endoscopy was compared between groups

Population: 178 participants were enrolled for 180 procedures

Procedures with post endoscopy reported symptoms, up to 4 hours, of belching, bloating and flatulence

Outcome measures

Measure	Air for Insufflation n=89 Procedures In this arm of patients, air which is currently used as standard of care will be used for insufflation Air: Air is the standard of practice and will be used in the control arm	Carbon Dioxide Gas for Insufflation n=91 Procedures in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air
Procedures With Post Endoscopy Reported Symptoms Belching	18 procedures	31 procedures
Procedures With Post Endoscopy Reported Symptoms Bloating	13 procedures	5 procedures
Procedures With Post Endoscopy Reported Symptoms Flatulence	26 procedures	9 procedures

Adverse Events

Air for Insufflation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Carbon Dioxide Gas for Insufflation

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Air for Insufflation n=88 participants at risk In this arm of patients, air which is currently used as standard of care will be used for insufflation Air: Air is the standard of practice and will be used in the control arm	Carbon Dioxide Gas for Insufflation n=90 participants at risk in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy Carbon dioxide gas for insufflation: Carbon dioxide gas use for insufflation during endoscopy instead of air
Gastrointestinal disorders Procedural related complication - Bleeding	0.00% 0/88 • Adverse event data was collected from start of procedure time up to 4 hours post procedure All cause Mortality Procedural related adverse events included bleeding and perforation Anesthesia related adverse events reported included hypoxia and aspiration	2.2% 2/90 • Number of events 2 • Adverse event data was collected from start of procedure time up to 4 hours post procedure All cause Mortality Procedural related adverse events included bleeding and perforation Anesthesia related adverse events reported included hypoxia and aspiration
Respiratory, thoracic and mediastinal disorders Anesthesia related complication - Aspiration	0.00% 0/88 • Adverse event data was collected from start of procedure time up to 4 hours post procedure All cause Mortality Procedural related adverse events included bleeding and perforation Anesthesia related adverse events reported included hypoxia and aspiration	2.2% 2/90 • Number of events 2 • Adverse event data was collected from start of procedure time up to 4 hours post procedure All cause Mortality Procedural related adverse events included bleeding and perforation Anesthesia related adverse events reported included hypoxia and aspiration
Respiratory, thoracic and mediastinal disorders Anesthesia related complication - Hypoxia	1.1% 1/88 • Number of events 1 • Adverse event data was collected from start of procedure time up to 4 hours post procedure All cause Mortality Procedural related adverse events included bleeding and perforation Anesthesia related adverse events reported included hypoxia and aspiration	0.00% 0/90 • Adverse event data was collected from start of procedure time up to 4 hours post procedure All cause Mortality Procedural related adverse events included bleeding and perforation Anesthesia related adverse events reported included hypoxia and aspiration

Additional Information

Dr. Warren Bishop, Professor of Pediatrics

University of Iowa

Phone: 319 356 2977

Email: warren-bishop@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place