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N/A Completed N=263 Randomized Triple-blind Prevention

Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound?

Source: ClinicalTrials.gov NCT00675415 ↗
Enrolled (actual)
263
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Number of Participants Experiencing Hypoxemia During Endoscopy — 57; 85 Participants

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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