Biliary Tract Diseases, Pancreatic Diseases
Conditions
Keywords
ERCP, Endoscopic Procedures, Anesthesia
Brief summary
Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation
Detailed description
Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are unconscious. The breathing tube is inserted with a patient laying on his/her back using a rigid metallic device (laryngoscope) to guide tube placement. The unconscious patient is then moved from the portable bed onto the X-ray table by nursing staff. The patient also has to be turned to lie on their stomach on the X-ray table for the procedure. This standard approach carries a small risk of patient injury during breathing tube placement as well as while moving and turning the unconscious patient onto the X-ray table. At our endoscopy unit, endoscopists have, on several occasions, used a slim gastroscope to place the breathing tube under direct visualization in patients who are already positioned on their stomach for ERCP. This approach is rapid and has been uniformly successful and safe. We hypothesize that this endoscopist-facilitated intubation approach may expedite the procedure and minimize ergonomic strain for staff during patient repositioning while minimizing patient injury during breathing tube placement and repositioning. This study seeks to formally compares the two approaches for placement of a breathing tube.
Interventions
PROCEDUREEndoscope assisted endotracheal intubation [EAEI]
Endoscope assisted endotracheal intubation \[EAEI\] performed by anesthesiologist with endoscopist assistance.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing ERCP at Stanford University Medical Center
Exclusion criteria
* Unable to consent * Contra-indication to general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Procedure Start | up to 1 hour | Time from patient entry into procedure room to insertion of endoscope/start of procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient positioning time | up to 1 hour | Recorded in endoscopy suite |
| Staff required for patient positioning | up to 20 minutes | Recorded in endoscopy suite, # of staff |
| Staff survey/assessment of ergonomic strain | up to 1 hour | Staff reporting of ergonomic strain encountered during the procedure scale of 1-5 to rate ergonomic strain, |
| Need for special positioning equipment | up to 20 minutes | Documented based on procedure room observation, list of equipment |
| Intubation Time (time from 'ready to intubate', to 'tube confirmation') | up to 1 hour | Endoscopy documentation |
| Time from removal of GI endoscope to exit from procedure room | up to 60 minutes | Documented in endoscopy suite |
| Tooth/oropharyngeal trauma, skin/musculoskeletal trauma | up to 24 hours post-procedure | Evaluation of oropharyngeal trauma and skin/musculoskeletal complaints following intubation, rating scale (0-5 to rate damage) |
| Materials and facility fees | up to 24 hours post-procedure | assessment of cost associated with procedures |
| Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension | up to 20 minutes | Evaluation of hypoxia during intubation |
Countries
United States
Contacts
Primary ContactSubhas Banerjee
Outcome results
None listed