Comparison of Standard and Endoscope Assisted Endotracheal Intubation
- Conditions
- Biliary Tract DiseasesPancreatic Diseases
- Interventions
- Procedure: Endoscope assisted endotracheal intubation [EAEI]
- Registration Number
- NCT03879720
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Patients undergoing ERCP at Stanford University Medical Center
- Unable to consent
- Contra-indication to general anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Endotracheal Intubation (SEI) Endoscope assisted endotracheal intubation [EAEI] the patient will be positioned supine on the gurney for intubation, with eventual position in the standard semi-prone ERCP position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed, Propofol and Succinylcholine will be administered per standard of care and intubation will be accomplished by direct laryngoscopy or glidescope, with confirmation of endotracheal tube placement by auscultation. Endoscope assisted endotracheal intubation [EAEI] Endoscope assisted endotracheal intubation [EAEI] the patients will position themselves in the semi-prone position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed and Propofol will be administered per standard of care. Succinylcholine will not be administered and therefore the patient will not be paralyzed. The endotracheal tube will be positioned on the mid-distal aspect of the ultra-slim endoscope and the ultra-slim endoscope will then be advanced into the trachea under direct endoscopic visualization to the level of the carina. The anesthesiologist will then advance the endotracheal tube over the endoscope into the trachea, and its position above the carina will be simultaneously confirmed endoscopically with the ultra-slim endoscope.
- Primary Outcome Measures
Name Time Method Time to Procedure Start up to 1 hour Time from patient entry into procedure room to insertion of endoscope/start of procedure
- Secondary Outcome Measures
Name Time Method Intubation Time (time from 'ready to intubate', to 'tube confirmation') up to 1 hour Endoscopy documentation
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
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)
Patient positioning time up to 1 hour Recorded in endoscopy suite
Need for special positioning equipment up to 20 minutes Documented based on procedure room observation, list of equipment
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,
Trial Locations
- Locations (1)
Stanford University Medical Center
🇺🇸Stanford, California, United States