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OpenTrials
Completed

NCT Number: NCT00675415

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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. The primary outcome of our study is the proportion of patients with hypoxemia in the two arms. Review of the literature indicates that the incidence of hypoxemia without supplemental oxygen varies from 30-70%. Our sample size calculation is based on a reduction of the hypoxemia incidence from 40% to 20%. Secondary outcomes will be the proportions of patients with oxygen requirements, major hypoxemia and apnea (lack of respiratory activity via capnography for at least 15 seconds) in the two arms. We will perform a univariable and multivariable analysis to determine the risk factors for apnea.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capnography

Diagnostic Test

Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity

Other names: Oridion Capnomater and CapnoBiteBloc

Primary outcomes

  1. Number of Participants Experiencing Hypoxemia During Endoscopy

    Time frame: Continuously Assessed during a single endoscopic procedure, typically about 2 hours

    Hypoxemia was defined as oxygen saturation less than 90 percent for at least 15 seconds.

Secondary outcomes

  1. Proportion of Participants Requiring Supplemental Oxygen

    Time frame: Continuously measured during endoscopy, typically about 2 hours

  2. Proportion of Participants Experiencing Severe Hypoxemia

    Time frame: Continuously measured during endoscopy, typically about 2 hours

  3. Proportion of Participants Experiencing Apnea

    Time frame: Continuously measured during endoscopy, typically about 2 hours

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Does Capnography Prevent Hypoxemia During ERCP and EUS? A Randomized, Controlled Trial

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 9, 2008
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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