Trial Outcomes & Findings for Use of Capnography in EGD and Colonoscopy With Moderate Sedation. (NCT NCT01994785)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

452 participants

Primary outcome timeframe

One day--data is collected during one endoscopic procedure.

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	EGD Capnography Open Capnographic monitoring during EGD - Data made available to study staff throughout procedure Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	EGD Capnography Blinded Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	Colonoscopy Capnography Open Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	Colonoscopy Capnography Blinded Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring
Overall Study STARTED	109	109	117	117
Overall Study COMPLETED	101	108	117	114
Overall Study NOT COMPLETED	8	1	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Capnography in EGD and Colonoscopy With Moderate Sedation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EGD Capnography Open n=101 Participants Capnographic monitoring during EGD - Data made available to study staff throughout procedure Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	EGD Capnography Blinded n=108 Participants Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	Colonoscopy Capnography Open n=117 Participants Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	Colonoscopy Capnography Blinded n=114 Participants Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	Total n=440 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 17.3 • n=5 Participants	49.8 years STANDARD_DEVIATION 17.0 • n=7 Participants	54.1 years STANDARD_DEVIATION 13.8 • n=5 Participants	55.3 years STANDARD_DEVIATION 13.3 • n=4 Participants	54.6 years STANDARD_DEVIATION 13.9 • n=21 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	69 Participants n=7 Participants	58 Participants n=5 Participants	59 Participants n=4 Participants	251 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	39 Participants n=7 Participants	59 Participants n=5 Participants	55 Participants n=4 Participants	189 Participants n=21 Participants
Region of Enrollment United States	101 participants n=5 Participants	108 participants n=7 Participants	117 participants n=5 Participants	114 participants n=4 Participants	440 participants n=21 Participants

PRIMARY outcome

Timeframe: One day--data is collected during one endoscopic procedure.

Outcome measures

Outcome measures
Measure	EGD Capnography Open n=109 Participants Capnographic monitoring during EGD - Data made available to study staff throughout procedure Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	EGD Capnography Blinded n=109 Participants Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	Colonoscopy Capnography Open n=117 Participants Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring	Colonoscopy Capnography Blinded n=117 Participants Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons Capnographic Monitoring: Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring
Number of Participants Experiencing Hypoxia During Capnography Monitoring.	54 Participants	59 Participants	61 Participants	63 Participants

Adverse Events

EGD Capnography Open

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EGD Capnography Blinded

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Colonoscopy Capnography Open

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Colonoscopy Capnography Blinded

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

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