Clinical trial NCT00675415: Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound?
Official title: Does Capnography Prevent Hypoxemia During ERCP and EUS? A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Keywords: Hypoxemia
Capnography
Apnea
Sedation
ERCP
EUS
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-05-09
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

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

Primary outcomes:
measure: Number of Participants Experiencing Hypoxemia During Endoscopy
timeFrame: Continuously Assessed during a single endoscopic procedure, typically about 2 hours
Secondary outcomes:
measure: Proportion of Participants Requiring Supplemental Oxygen
timeFrame: Continuously measured during endoscopy, typically about 2 hours
measure: Proportion of Participants Experiencing Severe Hypoxemia
timeFrame: Continuously measured during endoscopy, typically about 2 hours
measure: Proportion of Participants Experiencing Apnea
timeFrame: Continuously measured during endoscopy, typically about 2 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: John J Vargo, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.