HypoxemiaNCT00675415
Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound?
A study testing Capnography in people with Hypoxemia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Capnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2008
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 or greater
- Subjects undergoing elective ERCP and EUS
- ASA class 1-3
- Inpatient and outpatient
- Able to give informed consent
Who cannot join
- ASA Class 4 and 5
- Emergent procedures
- Procedures requiring MAC sedation
- Subjects unable to give informed consent
- Subjects on oxygen before procedure
- Subjects on CPAP/BiPAP
- Allergies to fentanyl/demerol/midazolam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Capnography Prevent Hypoxemia During ERCP and EUS? A Randomized, Controlled Trial
Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. In the capnography titration arm, the endoscopy team would be made aware of capnographic abnormalities as they arise throughout the procedure. In the capnography blinded arm, this information will not be available to the endoscopy team and represents standard of care. It is our hypothesis that using capnography can prevent low oxygen levels known as hypoxemia, during these procedures.
Read the detailed description
Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. In the capnography titration arm, the endoscopy team would be made aware of capnographic abnormalities as they arise throughout the procedure. In the capnography blinded arm, this information will not be available to the endoscopy team and represents standard of care. It is our hypothesis that using capnography can prevent low oxygen levels known as hypoxemia, during these procedures. The primary outcome of our study is the proportion of patients with hypoxemia in the two arms. Review of the literature indicates that the incidence of hypoxemia without supplemental oxygen varies from 30-70%. Our sample size calculation is based on a reduction of the hypoxemia incidence from 40% to 20%. Secondary outcomes will be the proportions of patients with oxygen requirements, major hypoxemia and apnea (lack of respiratory activity via capnography for at least 15 seconds) in the two arms. We will perform a univariable and multivariable analysis to determine the risk factors for apnea.
- Conditions
- Hypoxemia
- Being tested
- Capnography
- Keywords
- Hypoxemia, Capnography, Apnea, Sedation, ERCP, EUS
- Medical subject headings
- Hypoxia, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyDiagnostic test
Also called Oridion Capnomater and CapnoBiteBloc
Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity
| Study group | Role | What they receive |
|---|---|---|
| Capnography | Active comparator | 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. Receives: Diagnostic Test: Capnography |
| Standard Monitoring | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Hypoxemia During Endoscopy
Hypoxemia was defined as oxygen saturation less than 90 percent for at least 15 seconds.
Measured: Continuously Assessed during a single endoscopic procedure, typically about 2 hours
Secondary outcomes (3)
Proportion of Participants Requiring Supplemental Oxygen
Measured: Continuously measured during endoscopy, typically about 2 hours
Proportion of Participants Experiencing Severe Hypoxemia
Measured: Continuously measured during endoscopy, typically about 2 hours
Proportion of Participants Experiencing Apnea
Measured: Continuously measured during endoscopy, typically about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
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 HypoxemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Vargo, The Cleveland Clinic
- Investigators
- John J Vargo, M.D., M.P.H., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675415
- Sponsor's protocol ID
- IRB#06-681
- Status last verified
- Oct 2017
- First submitted
- 30 Mar 2008
- Last updated
- 28 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
PubMed 19422079
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Capnography Prevent Hypoxemia During ERCP and EUS? A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00675415
- Acronym / sponsor ID
- IRB#06-681
- Conditions
- Hypoxemia
- Keywords
- Hypoxemia, Capnography, Apnea, Sedation, ERCP, EUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. In the capnography titration arm, the endoscopy team would be made aware of capnographic abnormalities as they arise throughout the procedure. In the capnography blinded arm, this information will not be available to the endoscopy team and represents standard of care. It is our hypothesis that using capnography can prevent low oxygen levels known as hypoxemia, during these procedures.
Detailed description
Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In addition, capnography which measures carbon dioxide levels and can graphically assess respiratory activity will be used. Subjects will be randomized to either a capnography blinded or titration arm. In the capnography titration arm, the endoscopy team would be made aware of capnographic abnormalities as they arise throughout the procedure. In the capnography blinded arm, this information will not be available to the endoscopy team and represents standard of care. It is our hypothesis that using capnography can prevent low oxygen levels known as hypoxemia, during these procedures. The primary outcome of our study is the proportion of patients with hypoxemia in the two arms. Review of the literature indicates that the incidence of hypoxemia without supplemental oxygen varies from 30-70%. Our sample size calculation is based on a reduction of the hypoxemia incidence from 40% to 20%. Secondary outcomes will be the proportions of patients with oxygen requirements, major hypoxemia and apnea (lack of respiratory activity via capnography for at least 15 seconds) in the two arms. We will perform a univariable and multivariable analysis to determine the risk factors for apnea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capnography | Active comparator | Diagnostic Test: CapnographyCapnography: 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. |
| Standard Monitoring | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age 18 or greater
- Subjects undergoing elective ERCP and EUS
- ASA class 1-3
- Inpatient and outpatient
- Able to give informed consent
Key exclusion criteria (7 listed)
- ASA Class 4 and 5
- Emergent procedures
- Procedures requiring MAC sedation
- Subjects unable to give informed consent
- Subjects on oxygen before procedure
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 |
|---|---|---|
| CapnographyAlso: Oridion Capnomater and CapnoBiteBlocCapnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity | Diagnostic test | Capnography |
Primary outcome
Number of Participants Experiencing Hypoxemia During Endoscopy
Time frame: 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.
3 secondary outcomes
Proportion of Participants Requiring Supplemental Oxygen
Time frame: Continuously measured during endoscopy, typically about 2 hours
Proportion of Participants Experiencing Severe Hypoxemia
Time frame: Continuously measured during endoscopy, typically about 2 hours
Proportion of Participants Experiencing Apnea
Time frame: Continuously measured during endoscopy, typically about 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19422079Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
- 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, M.D., M.P.H. 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 Capnography in people with Hypoxemia, 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 5 inclusion and 7 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 28 Nov 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 30 May 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 Hypoxemia During Endoscopy (time frame: Continuously Assessed during a single endoscopic procedure, typically about 2 hours). 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 NCT00675415, 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 28 Nov 2017.