Trial Outcomes & Findings for Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound? (NCT NCT00675415)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

263 participants

Primary outcome timeframe

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

Results posted on

2017-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	Capnography 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. Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity	Standard Monitoring 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.
Overall Study STARTED	132	131
Overall Study COMPLETED	124	123
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capnography n=124 Participants 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. Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity	Standard Monitoring n=123 Participants 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.	Total n=247 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 14.4 • n=5 Participants	60.6 years STANDARD_DEVIATION 14.3 • n=7 Participants	60.7 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	61 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	62 Participants n=7 Participants	123 Participants n=5 Participants
Region of Enrollment United States	124 participants n=5 Participants	123 participants n=7 Participants	247 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Capnography n=124 Participants 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. Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity	Standard Monitoring n=123 Participants 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.
Number of Participants Experiencing Hypoxemia During Endoscopy	57 Participants	85 Participants

SECONDARY outcome

Timeframe: Continuously measured during endoscopy, typically about 2 hours

Outcome measures

Outcome measures
Measure	Capnography n=124 Participants 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. Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity	Standard Monitoring n=123 Participants 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.
Proportion of Participants Requiring Supplemental Oxygen	65 Participants	82 Participants

SECONDARY outcome

Timeframe: Continuously measured during endoscopy, typically about 2 hours

Outcome measures

Outcome measures
Measure	Capnography n=124 Participants 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. Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity	Standard Monitoring n=123 Participants 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.
Proportion of Participants Experiencing Severe Hypoxemia	19 Participants	38 Participants

SECONDARY outcome

Timeframe: Continuously measured during endoscopy, typically about 2 hours

Outcome measures

Outcome measures
Measure	Capnography n=124 Participants 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. Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity	Standard Monitoring n=123 Participants 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.
Proportion of Participants Experiencing Apnea	51 Participants	77 Participants

Adverse Events

Capnography

Serious events: 0 serious events

Other events: 101 other events

Deaths: 0 deaths

Standard Monitoring

Serious events: 0 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Capnography n=124 participants at risk 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. Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity	Standard Monitoring n=123 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Abnormal Breathing	81.5% 101/124 • Measured continuously during each participant's endoscopic procedure, typically about two hours Capnography Monitoring system provides continuous measurement of breathing, pulse, and oxygen saturation information.	77.2% 95/123 • Measured continuously during each participant's endoscopic procedure, typically about two hours Capnography Monitoring system provides continuous measurement of breathing, pulse, and oxygen saturation information.
Respiratory, thoracic and mediastinal disorders Hypoxemia	46.0% 57/124 • Measured continuously during each participant's endoscopic procedure, typically about two hours Capnography Monitoring system provides continuous measurement of breathing, pulse, and oxygen saturation information.	69.1% 85/123 • Measured continuously during each participant's endoscopic procedure, typically about two hours Capnography Monitoring system provides continuous measurement of breathing, pulse, and oxygen saturation information.
Blood and lymphatic system disorders Hypotension	8.1% 10/124 • Measured continuously during each participant's endoscopic procedure, typically about two hours Capnography Monitoring system provides continuous measurement of breathing, pulse, and oxygen saturation information.	4.9% 6/123 • Measured continuously during each participant's endoscopic procedure, typically about two hours Capnography Monitoring system provides continuous measurement of breathing, pulse, and oxygen saturation information.

Additional Information

Dr. John Vargo

Cleveland Clinic

Phone: (216) 445-5012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place