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Use of Capnography in EGD and Colonoscopy With Moderate Sedation.

Primary Purpose

Hypoxia, Apnea, Hypotension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Capnographic Monitoring
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxia focused on measuring Sedation, Endoscopy, Capnography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

EGD capnography open

EGD capnography blinded

Colonoscopy capnography open

Colonoscopy capnography blinded

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Hypoxia During Capnography Monitoring.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2013
Last Updated
May 30, 2017
Sponsor
The Cleveland Clinic
Collaborators
American College of Gastroenterology
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1. Study Identification

Unique Protocol Identification Number
NCT01994785
Brief Title
Use of Capnography in EGD and Colonoscopy With Moderate Sedation.
Official Title
Does the Use of Capnography in Routine EGD and Colonoscopy Targeting Moderate Sedation With a Benzodiazepine and Opioid Improve Safety?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
American College of Gastroenterology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The majority of gastrointestinal endoscopic procedures currently performed in the United States are done under moderate sedation, primarily utilizing the combination of an opioid and benzodiazepine. The endoscopy team administers the medications, most commonly the endoscopy nursing team at the discretion of the endoscopist, with careful cardiopulmonary monitoring during the procedure. The use of sedation can lead to serious unplanned adverse events. Cardiopulmonary events related to the use of sedation in GI endoscopy include hypotension, hypoxia, and hypopnea/apnea. The most common of these adverse events is hypoxia, which can occur in 10-70% of patients. Although most of these events are transient and respond to supplemental oxygenation, studies have shown electrocardiographic signs of cardiac ischemia in patients with no known preexisting heart disease. Pulse oximetry can help detect hypoxia related to perfusion deficits (cardiac) or ventilation factors (respiratory) however, it is not designed to detect ventilator precursors of alveolar hypoventilation, which primarily present as decreased respiratory rate or hypopnea/apnea. Capnography utilizes the near-infrared spectrophotometric absorption spectrum of carbon dioxide (CO2) at 420 nm to provide graphic assessment of the ventilation status via the partial pressure of carbon dioxide during the respiratory cycle. Previous studies have shown it to improve safety by detecting early indicators of hypoxia and/or signs of alveolar hypoventilation. Studies have shown that when targeting deep sedation in advanced endoscopic procedures utilizing capnography was superior to pulse oximetry alone in detecting respiratory depression. There is also evidence that shows utilizing capnography in advanced endoscopic procedures significantly decreased the incidence of hypoxia versus standard monitoring with the procedural team blinded to the capnographic data (132 blinded vs. 49 open, P<.001) and rates of hypoxia (69% blinded vs. 46% open, P<.001) were significantly lower with capnography monitoring. Routine esophagogastroduodenoscopy (EGD) and colonoscopy with moderate sedation is safe with rates of sedation associated adverse events occurring in 8 per 100,000 cases. Lightdale and colleagues showed in a prospective, double blinded randomized controlled trial in a pediatric population undergoing routine EGD or colonoscopy targeting moderate sedation with opioid-benzodiazepine combinations that patients in the intervention capnography arm were less likely (4% vs. 20%, P<.03) to have an intra-procedural episodes of hypoxia (defined as SpO2<95% for >5sec). No adverse events related to episodes of hypoxia were reported in this trial, but it was underpowered to evaluate this outcome. To our knowledge, there is no data on use of capnography in adult patients undergoing EGD and colonoscopy targeting moderate sedation with the combination of an opioid and benzodiazepine. The American Society of Anesthesiology (ASA) has recently updated their standards for basic anesthetic monitoring to now state that during moderate sedation all patients should have capnographic monitoring. This was updated from the previous standards for basic monitoring that stated capnography could be used during these levels of sedation. This is a significant change in the practice model for monitoring patients undergoing routine endoscopy with moderate sedation and, as the standards for basic monitoring are often used as a basis for regulatory guidelines applied to hospital or ambulatory care centers, the addition of requiring capnographic monitoring changes the landscape of procedural sedation for gastrointestinal endoscopy across the United States. The evidence cited for this update in monitoring guidelines included the Lightdale pediatric endoscopy study and our groups study that utilized capnography in advanced endoscopic procedures. There was no data available in adult patients undergoing routine EGD or colonoscopy at the time of the updated guidelines. The extrapolation of advanced endoscopic procedures to routine endoscopy is of limited use as the procedures are targeting different levels of sedation (deep vs. moderate, respectively) and the length of the procedures is significantly different. The rationale for not using capnography in moderate sedation arises from its ability to lead to false alarms, such as pseudo-apnea secondary to swallowing or failure to monitor both the oral and nasal airways for respiratory activity, as some patients will transition to nasal or mouth breathing during sedation. These alarms during a procedure may lead to interruption, delay, or early termination. Increased costs for capnography equipment and having appropriately trained endoscopy team members to interpret capnography results will be difficult to accomplish with no patient data supporting the effectiveness of its use in routine EGD and colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Apnea, Hypotension, Hypopnea
Keywords
Sedation, Endoscopy, Capnography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGD capnography open
Arm Type
Active Comparator
Arm Description
Capnographic monitoring during EGD - Data made available to study staff throughout procedure
Arm Title
EGD capnography blinded
Arm Type
Active Comparator
Arm Description
Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons
Arm Title
Colonoscopy capnography open
Arm Type
Active Comparator
Arm Description
Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure
Arm Title
Colonoscopy capnography blinded
Arm Type
Active Comparator
Arm Description
Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons
Intervention Type
Diagnostic Test
Intervention Name(s)
Capnographic Monitoring
Intervention Description
Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Hypoxia During Capnography Monitoring.
Time Frame
One day--data is collected during one endoscopic procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18yrs with full decision making capacity Scheduled for elective upper endoscopy or colonoscopy with moderate sedation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Vargo, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26902229
Citation
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.
Results Reference
derived

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Use of Capnography in EGD and Colonoscopy With Moderate Sedation.

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