NCT01994785

Brief Summary

This study will provide capnography monitoring during routine upper endoscopy and colonoscopy with moderate sedation in order to see if it improves safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

November 18, 2013

Results QC Date

April 20, 2017

Last Update Submit

May 30, 2017

Conditions

HypoxiaApneaHypotensionHypopnea

Keywords

SedationEndoscopyCapnography

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Experiencing Hypoxia During Capnography Monitoring.

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

Study Arms (4)

EGD capnography open

ACTIVE COMPARATOR

Capnographic monitoring during EGD - Data made available to study staff throughout procedure

Diagnostic Test: Capnographic Monitoring

EGD capnography blinded

ACTIVE COMPARATOR

Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons

Diagnostic Test: Capnographic Monitoring

Colonoscopy capnography open

ACTIVE COMPARATOR

Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure

Diagnostic Test: Capnographic Monitoring

Colonoscopy capnography blinded

ACTIVE COMPARATOR

Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons

Diagnostic Test: Capnographic Monitoring

Interventions

Capnographic MonitoringDIAGNOSTIC_TEST

Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring

Colonoscopy capnography blindedColonoscopy capnography openEGD capnography blindedEGD capnography open

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18yrs with full decision making capacity
  • Scheduled for elective upper endoscopy or colonoscopy with moderate sedation

You may not qualify if:

  • ASAPS class III or higher.
  • History of a demonstrated allergy or intolerance to a benzodiazepine or opioid
  • Patients scheduled for both upper endoscopy and colonoscopy during the same endoscopy day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Independence, Ohio, 44131, United States

Location

Related Publications (1)

  • Mehta PP, Kochhar G, Albeldawi M, Kirsh B, Rizk M, Putka B, John B, Wang Y, Breslaw N, Lopez R, Vargo JJ. Capnographic Monitoring in Routine EGD and Colonoscopy With Moderate Sedation: A Prospective, Randomized, Controlled Trial. Am J Gastroenterol. 2016 Mar;111(3):395-404. doi: 10.1038/ajg.2015.437. Epub 2016 Feb 23.

    PMID: 26902229DERIVED

MeSH Terms

Conditions

HypoxiaApneaHypotension

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
John Vargo
Organization
Cleveland Clinic
vargoj@ccf.org
216 445-5012

Study Officials

  • John J Vargo, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Chairman, Gastroenterology and Hepatology

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 26, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

July 2, 2017

Results First Posted

July 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)