Comparison of Standard and Endoscope Assisted Endotracheal Intubation

Study Overview
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Brief Summary
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Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

Detailed Description
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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.

Official Title
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Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]

Conditions
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Biliary Tract Diseases, Pancreatic Diseases

Intervention / Treatment
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* Procedure: Endoscope assisted endotracheal intubation [EAEI]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ERCP at Stanford University Medical Center Exclusion Criteria: Unable to consent Contra-indication to general anesthesia
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Endotracheal Intubation (SEI)<br>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. | Procedure: Endoscope assisted endotracheal intubation [EAEI]<br>* Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.<br>* Other names: Standard Endotracheal Intubation [SEI];|
| Experimental: Endoscope assisted endotracheal intubation [EAEI]<br>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. | Procedure: Endoscope assisted endotracheal intubation [EAEI]<br>* Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.<br>* Other names: Standard Endotracheal Intubation [SEI];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Procedure Start | Time from patient entry into procedure room to insertion of endoscope/start of procedure | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Time (time from 'ready to intubate', to 'tube confirmation') | Endoscopy documentation | up to 1 hour | 
| Patient positioning time | Recorded in endoscopy suite | up to 1 hour | 
| Staff required for patient positioning | Recorded in endoscopy suite, # of staff | up to 20 minutes | 
| Staff survey/assessment of ergonomic strain | Staff reporting of ergonomic strain encountered during the procedure scale of 1-5 to rate ergonomic strain, | up to 1 hour | 
| Need for special positioning equipment | Documented based on procedure room observation, list of equipment | up to 20 minutes | 
| Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension | Evaluation of hypoxia during intubation | up to 20 minutes | 
| Time from removal of GI endoscope to exit from procedure room | Documented in endoscopy suite | up to 60 minutes | 
| Tooth/oropharyngeal trauma, skin/musculoskeletal trauma | Evaluation of oropharyngeal trauma and skin/musculoskeletal complaints following intubation, rating scale (0-5 to rate damage) | up to 24 hours post-procedure | 
| Materials and facility fees | assessment of cost associated with procedures | up to 24 hours post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Endoscopic Procedures, Anesthesia