Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound? - Full Text View

Purpose

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.

Condition	Intervention
Hypoxemia	Device: Capnography (Specific device name: Capnostream 20) Device: Sham

MedlinePlus related topics:

Endoscopy

Drug Information available for:

Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Proportion of patients with hypoxemia in the two arms [ Time Frame: Hypoxemia during ERCP and EUS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Risk factors for apnea via univariate and multivariate analysis [ Time Frame: Pre- and intraprocedural measurments ] [ Designated as safety issue: Yes ]
Proportion of patients with oxygen requirements, major hypoxemia, apnea and hypoventilation in the two arms. [ Time Frame: Pre- and intraprocedural measurments ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	263
Study Start Date:	September 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.	Device: Capnography (Specific device name: Capnostream 20) Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity
2: Sham Comparator Subjects randomized to capnography-blinded arm: The endoscopy team would be made aware of capnographic abnormalities (apnea) if they persist for >30 seconds.	Device: Sham sham

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675415

Locations


United States, Ohio
	Cleveland Clinic Foundation
	Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators


Principal Investigator:	John J Vargo, M.D., M.P.H.	The Cleveland Clinic

More Information

Responsible Party:	Department of Gastroenterology and Hepatology, Cleveland Clinic Foundation ( John J. Vargo, M.D., M.P.H. )
Study ID Numbers:	IRB#06-681
First Received:	March 30, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00675415
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

Hypoxemia

Capnography

Apnea

Sedation

ERCP

EUS

Study placed in the following topic categories:

Signs and Symptoms

Apnea

Signs and Symptoms, Respiratory

Anoxia

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00675415