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

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675415
• Other study ID #: IRB#06-681
• Status: Completed
• Phase: N/A
• First received: March 30, 2008
• Last updated: October 24, 2017
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: October 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Hypoxemia During Endoscopy	Hypoxemia was defined as oxygen saturation less than 90 percent for at least 15 seconds.	Continuously Assessed during a single endoscopic procedure, typically about 2 hours
Secondary	Proportion of Participants Requiring Supplemental Oxygen		Continuously measured during endoscopy, typically about 2 hours
Secondary	Proportion of Participants Experiencing Severe Hypoxemia		Continuously measured during endoscopy, typically about 2 hours
Secondary	Proportion of Participants Experiencing Apnea		Continuously measured during endoscopy, typically about 2 hours