HypoxiaNCT01994785
Use of Capnography in EGD and Colonoscopy With Moderate Sedation.
A study testing Capnographic Monitoring in people with Hypoxia and Apnea, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study will provide capnography monitoring during routine upper endoscopy and colonoscopy with moderate sedation in order to see if it improves safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Apnea, Hypotension
- What is being tested?
- Capnographic Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18yrs with full decision making capacity
- Scheduled for elective upper endoscopy or colonoscopy with moderate sedation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Use of Capnography in Routine EGD and Colonoscopy Targeting Moderate Sedation With a Benzodiazepine and Opioid Improve Safety?
This study will provide capnography monitoring during routine upper endoscopy and colonoscopy with moderate sedation in order to see if it improves safety.
Read the 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.
- Conditions
- Hypoxia, Apnea, Hypotension, Hypopnea
- Being tested
- Capnographic Monitoring
- Keywords
- Sedation, Endoscopy, Capnography
- Medical subject headings
- Hypoxia, Apnea, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnographic MonitoringDiagnostic test
Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring
| Study group | Role | What they receive |
|---|---|---|
| EGD capnography open | Active comparator | Capnographic monitoring during EGD - Data made available to study staff throughout procedure Receives: 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 Receives: Diagnostic Test: Capnographic Monitoring |
| Colonoscopy capnography open | Active comparator | Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure Receives: 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 Receives: Diagnostic Test: Capnographic Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Hypoxia During Capnography Monitoring.
Measured: One day--data is collected during one endoscopic procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology
- Responsible party
- Principal investigator, John Vargo, The Cleveland Clinic
- Investigators
- John J Vargo, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994785
- Sponsor's protocol ID
- CC-13-792
- Status last verified
- May 2017
- First submitted
- 18 Nov 2013
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26902229
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Capnography in Routine EGD and Colonoscopy Targeting Moderate Sedation With a Benzodiazepine and Opioid Improve Safety?
- ClinicalTrials.gov ID
- NCT01994785
- Acronym / sponsor ID
- CC-13-792
- Conditions
- Hypoxia, Apnea, Hypotension, Hypopnea
- Keywords
- Sedation, Endoscopy, Capnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- American College of Gastroenterology
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EGD capnography open | Active comparator | Diagnostic Test: Capnographic MonitoringCapnographic monitoring during EGD - Data made available to study staff throughout procedure |
| EGD capnography blinded | Active comparator | Diagnostic Test: Capnographic MonitoringCapnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons |
| Colonoscopy capnography open | Active comparator | Diagnostic Test: Capnographic MonitoringCapnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure |
| Colonoscopy capnography blinded | Active comparator | Diagnostic Test: Capnographic MonitoringCapnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18yrs with full decision making capacity
- Scheduled for elective upper endoscopy or colonoscopy with moderate sedation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capnographic MonitoringCapnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring | Diagnostic test | Colonoscopy capnography blinded, Colonoscopy capnography open, EGD capnography blinded, EGD capnography open |
Primary outcome
Number of Participants Experiencing Hypoxia During Capnography Monitoring.
Time frame: One day--data is collected during one endoscopic procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26902229Mehta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Vargo, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capnographic Monitoring in people with Hypoxia and Apnea, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Hypoxia During Capnography Monitoring. (time frame: One day--data is collected during one endoscopic procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.