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

NCT00675415 | Completed Results

• 1 other identifier: IRB#06-681
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxemia

Keywords

Hypoxemia; Capnography; Apnea; Sedation; ERCP; EUS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of Participants Requiring Supplemental Oxygen

  Continuously measured during endoscopy, typically about 2 hours

• Proportion of Participants Experiencing Severe Hypoxemia

  Continuously measured during endoscopy, typically about 2 hours

• Proportion of Participants Experiencing Apnea

  Continuously measured during endoscopy, typically about 2 hours

Study Arms (2)

Capnography

ACTIVE COMPARATOR

Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise. In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography. This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.

Diagnostic Test: Capnography

Standard Monitoring

NO INTERVENTION

Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.

Interventions

Capnography DIAGNOSTIC_TEST

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

Also known as: Oridion Capnomater and CapnoBiteBloc

Capnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 or greater
• Subjects undergoing elective ERCP and EUS
• ASA class 1-3
• Inpatient and outpatient
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.

  PMID: 19422079 DERIVED

MeSH Terms

Conditions

Hypoxia; Apnea

Interventions

Capnography

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. John Vargo
• Organization: Cleveland Clinic

vargoj@ccf.org

(216) 445-5012

Study Officials

• John J Vargo, M.D., M.P.H.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: May 9, 2008
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 28, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)