N/A
N=263
Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound?
Hypoxemia
Bottom Line
View on ClinicalTrials.gov: NCT00675415 ↗Enrolled (actual)
263
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Number of Participants Experiencing Hypoxemia During Endoscopy — 57; 85 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capnography (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Hypoxemia During Endoscopy |
57; 85 | — |
| SECONDARY Proportion of Participants Requiring Supplemental Oxygen |
65; 82 | — |
| SECONDARY Proportion of Participants Experiencing Severe Hypoxemia |
19; 38 | — |
| SECONDARY Proportion of Participants Experiencing Apnea |
51; 77 | — |
Summary
Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. In the capnography titration arm, the endoscopy team would be made aware of capnographic abnormalities as they arise throughout the procedure. In the capnography blinded arm, this information will not be available to the endoscopy team and represents standard of care. It is our hypothesis that using capnography can prevent low oxygen levels known as hypoxemia, during these procedures.
Eligibility Criteria
Inclusion Criteria
- Adults age 18 or greater
- Subjects undergoing elective ERCP and EUS
- ASA class 1-3
- Inpatient and outpatient
- Able to give informed consent
Exclusion Criteria
- ASA Class 4 and 5
- Emergent procedures
- Procedures requiring MAC sedation
- Subjects unable to give informed consent
- Subjects on oxygen before procedure
- Subjects on CPAP/BiPAP
- Allergies to fentanyl/demerol/midazolam
Data sourced from ClinicalTrials.gov (NCT00675415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.