Hypoxemia
Conditions
Keywords
Hypoxemia, Capnography, Apnea, Sedation, ERCP, EUS
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTCapnography
Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults age 18 or greater * Subjects undergoing elective ERCP and EUS * ASA class 1-3 * Inpatient and outpatient * Able to give informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Hypoxemia During Endoscopy | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants Requiring Supplemental Oxygen | Continuously measured during endoscopy, typically about 2 hours |
| Proportion of Participants Experiencing Severe Hypoxemia | Continuously measured during endoscopy, typically about 2 hours |
| Proportion of Participants Experiencing Apnea | Continuously measured during endoscopy, typically about 2 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capnography 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.
Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity | 124 |
| Standard Monitoring 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. | 123 |
| Total | 247 |
Baseline characteristics
| Characteristic | Capnography | Standard Monitoring | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 14.4 | 60.6 years STANDARD_DEVIATION 14.3 | 60.7 years STANDARD_DEVIATION 14.3 |
| Region of Enrollment United States | 124 participants | 123 participants | 247 participants |
| Sex: Female, Male Female | 63 Participants | 61 Participants | 124 Participants |
| Sex: Female, Male Male | 61 Participants | 62 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 123 |
| other Total, other adverse events | 101 / 124 | 95 / 123 |
| serious Total, serious adverse events | 0 / 124 | 0 / 123 |
Outcome results
Primary
Number of Participants Experiencing Hypoxemia During Endoscopy
Hypoxemia was defined as oxygen saturation less than 90 percent for at least 15 seconds.
Time frame: Continuously Assessed during a single endoscopic procedure, typically about 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Capnography | Number of Participants Experiencing Hypoxemia During Endoscopy | 57 Participants |
| Standard Monitoring | Number of Participants Experiencing Hypoxemia During Endoscopy | 85 Participants |
Secondary
Proportion of Participants Experiencing Apnea
Time frame: Continuously measured during endoscopy, typically about 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Capnography | Proportion of Participants Experiencing Apnea | 51 Participants |
| Standard Monitoring | Proportion of Participants Experiencing Apnea | 77 Participants |
Secondary
Proportion of Participants Experiencing Severe Hypoxemia
Time frame: Continuously measured during endoscopy, typically about 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Capnography | Proportion of Participants Experiencing Severe Hypoxemia | 19 Participants |
| Standard Monitoring | Proportion of Participants Experiencing Severe Hypoxemia | 38 Participants |
Secondary
Proportion of Participants Requiring Supplemental Oxygen
Time frame: Continuously measured during endoscopy, typically about 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Capnography | Proportion of Participants Requiring Supplemental Oxygen | 65 Participants |
| Standard Monitoring | Proportion of Participants Requiring Supplemental Oxygen | 82 Participants |