Endoscopy
Conditions
Keywords
upper endoscopy, endoscope, abdominal discomfort, insufflation, carbon dioxide
Brief summary
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.
Detailed description
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.
Interventions
OTHERAir
Air will be used for luminal inflation.
OTHERCarbon Dioxide
Carbon dioxide will be used for luminal inflation.
Sponsors
Children's Hospital and Medical Center, Omaha, Nebraska
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blinded, prospective, randomized study
Intervention model description
Eligible study participants will be randomized 1:1 into two study arms; one receiving air and the other receiving carbon dioxide for luminal inflation.
Eligibility
Sex/Gender
ALL
Age
6 Months to 19 Years
Healthy volunteers
No
Inclusion criteria
* Children 6 months to 19 years old and * Undergoing upper endoscopy at Children's Hospital & Medical Center in Omaha, NE and * Parents or legal guardians consent to the study
Exclusion criteria
* Patients and legal guardians who decline participation in the study * Patients with chronic respiratory disease (defined as severe asthma, bronchopulmonary dysplasia and cystic fibrosis-related pulmonary disease) * Patients with cyanotic heart disease * Patients with an ASA status of ≥ 3. * Patients who are wards of the state or in foster care * Prisoners * Patients undergoing colonoscopy only procedures or procedures not related to upper endoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Procedures With Elevated End-tidal CO2 Levels | Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Abdominal Pain | This will be assessed before and after the procedure | Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure |
Countries
United States
Participant flow
Pre-assignment details
1 participant who consented withdrew consent prior to randomization. Therefore, this patient did not undergo randomization
Participants by arm
| Arm | Count |
|---|---|
| Air for Luminal Inflation Patients randomized into this arm will have luminal inflation using air.
Air: Air will be used for luminal inflation. | 98 |
| Air for Luminal Inflation Patients randomized into this arm will have luminal inflation using air.
Air: Air will be used for luminal inflation. | 98 |
| 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. | 102 |
| 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. | 102 |
| Total | 400 |
Baseline characteristics
| Characteristic | Air for Luminal Inflation | Carbon Dioxide for Luminal Inflation | Total |
|---|---|---|---|
| Age, Continuous | 12 years | 12 years | 12 years |
| BMI z score | 0.23 units on a scale | 0.61 units on a scale | 0.23 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Procedures | 6 Procedures | 12 Procedures |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Procedures | 96 Procedures | 188 Procedures |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Procedures | 0 Procedures | 0 Procedures |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Procedures | 0 Procedures | 0 Procedures |
| Race (NIH/OMB) Asian | 0 Procedures | 0 Procedures | 0 Procedures |
| Race (NIH/OMB) Black or African American | 1 Procedures | 0 Procedures | 1 Procedures |
| Race (NIH/OMB) More than one race | 6 Procedures | 10 Procedures | 16 Procedures |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Procedures | 0 Procedures | 0 Procedures |
| Race (NIH/OMB) Unknown or Not Reported | 7 Procedures | 8 Procedures | 15 Procedures |
| Race (NIH/OMB) White | 84 Procedures | 84 Procedures | 168 Procedures |
| Region of Enrollment United States | 98 participants | 102 participants | 200 participants |
| Sex: Female, Male Female | 58 Procedures | 56 Procedures | 114 Procedures |
| Sex: Female, Male Male | 40 Procedures | 46 Procedures | 86 Procedures |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 102 |
| other Total, other adverse events | 5 / 98 | 5 / 102 |
| serious Total, serious adverse events | 0 / 98 | 0 / 102 |
Outcome results
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
Time frame: Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.
Population: Participants in this groups refers to procedures. Procedure count was used for analysis and not participant count
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Air for Luminal Inflation | Number of Procedures With Elevated End-tidal CO2 Levels | 8 Procedures |
| Carbon Dioxide for Luminal Inflation | Number of Procedures With Elevated End-tidal CO2 Levels | 21 Procedures |
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
Time frame: This will be assessed before and after the procedure
Population: Participant procedures randomized into air or CO2 for endoscopic insufflation. Participants reporting abdominal pain after procedure. Higher numbers are worse
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Air for Luminal Inflation | Number of Participants Reporting Abdominal Pain | 14 participants |
| Carbon Dioxide for Luminal Inflation | Number of Participants Reporting Abdominal Pain | 15 participants |