Airway Anesthesia, Airway Control, Airway Management, Endoscopy, Digestive System
Conditions
Keywords
airway management, Upper endoscopy
Brief summary
This study will test an investigational bite block, which is a device placed inside the mouth to protect the teeth and used to keep the endoscope (a long, flexible tube that is placed down the throat and into the esophagus that contains a light and camera used to provide a visual of the area) in place. This Oxygenating bite block has been modified to allow the convenient use of an oral nasal cannula for administration of oxygen and sampling of end-tidal carbon dioxide (measurement of the amount of carbon dioxide exhaled at the end of a breath) during endoscopic procedures.
Detailed description
This study will last one day and is completely voluntary. The primary objective of this study is to evaluate the tolerability and efficacy of the device. The investigator will be testing how this device improves the flow of oxygen and provides safer sedation.
Interventions
DEVICEOxygenating Bite Block
Oxygenating Bite Block will be used instead of the standard bite block.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Pilot study (ten subjects)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Obese patients scheduled to undergo upper endoscopy, * Willingness and ability to sign an informed consent document, * ASA class I - III obese adults, * Subjects will be of diverse racial and ethnic backgrounds.
Exclusion criteria
* Patients deemed to be at significant airway risk, * Under 18 years of age, since there is no justification to include them, * Missing or loose incisor or canine teeth * Temporomandibular joint disease * Maxillofacial abnormalities (deformities of the jaw, lips, and tongue) * Pregnant women, since there is no justification to include them, * Emergency surgeries, * Any other conditions that may interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OBB Device Feasibility | During the upper endoscopy procedure | SPO2 -Subject desaturation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the Oxygenating Bite Block - Patients | After the endoscopy, up to 5 minutes | Questionnaire Satisfaction with the level of sedation and OBB tolerability? |
| Tolerability of the Oxygenating Bite Block - Anesthesiologist | After the endoscopy, up to 5 minutes | Questionnaire Was the OBB easy to use, protected the subject's oral cavity, and oxygenated effectively? |
| Tolerability of the Oxygenating Bite Block - Endoscopist | After the endoscopy, up to 5 minutes | Questionnaire - Endoscopist Did your patient tolerate the OBB well, and will you use it again? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxygenating Bite Block (OBB) During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB.
After the endoscopy procedure, the participant will be asked to complete a short questionnaire to find out their satisfaction with the level of sedation during the procedure, the tolerability of the device, and any discomfort.
OBB was used instead of the standard bite block. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Oxygenating Bite Block (OBB) |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
OBB Device Feasibility
SPO2 -Subject desaturation
Time frame: During the upper endoscopy procedure
Population: SpO2 \< 90%
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxygenating Bite Block (OBB) | OBB Device Feasibility | 3 Participants |
Secondary
Tolerability of the Oxygenating Bite Block - Anesthesiologist
Questionnaire Was the OBB easy to use, protected the subject's oral cavity, and oxygenated effectively?
Time frame: After the endoscopy, up to 5 minutes
Population: Anesthesiologists expressed that the OBB was easy to use, protected the subject's oral cavity, and oxygenated effectively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxygenating Bite Block (OBB) | Tolerability of the Oxygenating Bite Block - Anesthesiologist | 10 Participants |
Secondary
Tolerability of the Oxygenating Bite Block - Endoscopist
Questionnaire - Endoscopist Did your patient tolerate the OBB well, and will you use it again?
Time frame: After the endoscopy, up to 5 minutes
Population: Endoscopists expressed that the OBB was well tolerated and will you use it again.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxygenating Bite Block (OBB) | Tolerability of the Oxygenating Bite Block - Endoscopist | 10 Participants |
Secondary
Tolerability of the Oxygenating Bite Block - Patients
Questionnaire Satisfaction with the level of sedation and OBB tolerability?
Time frame: After the endoscopy, up to 5 minutes
Population: All subjects (100%) expressed satisfaction with the level of sedation and OBB tolerability
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxygenating Bite Block (OBB) | Tolerability of the Oxygenating Bite Block - Patients | 10 Participants |